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Clinical trials
catalyst calendar across sponsors →Studies where EW is the lead sponsor, as filed with ClinicalTrials.gov. Completion dates are the sponsor's own projected windows and are revised as a study runs. Active studies first, then completed and stopped — newest readout first within each.
83 interventional · 43 observational · 54 with posted results
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| Study | Phase | Status | Interventions | Conditions | Enrollment | Primary completion | Readout in | Updated |
|---|---|---|---|---|---|---|---|---|
| China S3 PMS: SAPIEN 3 China Post Market Registry StudyNCT05168826observationalAll-cause mortality | — | Active, not recruiting | Device: SAPIEN 3 Transcatheter Heart Valve | Aortic Stenosis, Severe | 250 | Dec 2035 | ≤ 3,421 d | 2026-08-12 |
| PARTNER 3 Trial - Aortic Valve-in-ValveNCT03003299Safety and Effectiveness - Non-hierarchical composite of all-cause mortality and strokeOpen-label · Treatment | Not applicable | Recruiting | Device: Edwards SAPIEN 3/SAPIEN 3 Ultra THV | Aortic Stenosis, Aortic Stenosis, Severe | 125 | Jan 2033 | ≤ 2,357 d | 2024-05-10 |
| Real World European Investigation of Safety and Clinical Efficacy of the EVOQUE System (TRISCEND III EU)NCT06569602observationalTricuspid regurgitation grade | — | Recruiting | Device: Transcatheter Tricuspid Valve Replacement | Tricuspid Valve Regurgitation, Heart Valve Diseases, Cardiovascular Diseases | 500 | 2030-09-30 | in 1,503 d | 2024-10-31 |
| COMPASSION S3 Post-Approval StudyNCT04860765observationalDevice Success | — | Active, not recruiting | Device: SAPIEN 3 THV | Complex Congenital Heart Defect, Dysfunctional RVOT Conduit, Pulmonary Valve Insufficiency, Pulmonary Valve Degeneration, Pulmonary Valve; Obstruction | 150 | Aug 2030 | ≤ 1,473 d | 2026-02-03 |
| TRIFORMIS RESILIA Real-world Study Assessing Safety and Performance (TRIBLAZE Study)NCT07684313observationalParticipant's average mean gradient measurement over time | — | Not yet recruiting | Device: Edwards TRIFORMIS RESILIA heart valve | Heart Valve Diseases, Heart Diseases, Cardiovascular Diseases, Tricuspid Valve Disease | 75 | Aug 2030 | ≤ 1,473 d | 2026-07-06 |
| PROGRESS: Management of Moderate Aortic Stenosis by Clinical Surveillance or TAVRNCT04889872Primary Effectiveness EndpointRandomized · Open-label · Treatment | Not applicable | Recruiting | Device: SAPIEN 3 / SAPIEN 3 Ultra / SAPIEN 3 Ultra RESILIA | Aortic Stenosis, Calcific, Aortic Valve Stenosis | 2,250 | Jun 2029 | ≤ 1,046 d | 2025-12-17 |
| ALLIANCE AVIV: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve in Failing Aortic Bioprosthetic ValvesNCT05172973Non-hierarchical composite of death and strokeNon-randomized · Open-label · Treatment | Not applicable | Recruiting | Device: SAPIEN X4/X4S THV | Aortic Valve Insufficiency, Aortic Valve Stenosis | 200 | Mar 2029 | ≤ 955 d | 2026-07-27 |
| ALLIANCE Mitral: Safety and Effectiveness of SAPIEN X4 Transcatheter Heart Valve - MitralNCT06167213Non-hierarchical composite of death and stroke at 1 yearNon-randomized · Open-label · Treatment | Not applicable | Not yet recruiting | Device: SAPIEN X4 THV | Mitral Regurgitation, Mitral Valve Disease, Mitral Stenosis | 125 | Mar 2029 | ≤ 955 d | 2025-12-22 |
| INSPIRIS China PMCF StudyNCT05404880observationalSubject's Occurrence Rate of Study Valve Related Death | — | Active, not recruiting | Device: EDWARDS INSPIRIS RESILIA Aortic Valve | Aortic Valve Replacement | 255 | Dec 2028 | ≤ 865 d | 2026-03-25 |
| MITRIS China Post Market Clinical Follow-up (PMCF) StudyNCT07059793observationalPrimary Safety outcome - Kaplan Meier (KM) rate of valve related death or reintervention | — | Recruiting | Device: MITRIS RESILIA Mitral Valve | Mitral Valve Replacement | 250 | Dec 2028 | ≤ 865 d | 2025-12-30 |
| KONECT RESILIA Aortic Valved Conduit (AVC) Real-world Study Assessing Safety and PerformanceNCT07619872observationalPercentage of participant's freedom from death and/or device related reintervention | — | Recruiting | Device: Edwards KONECT RESILIA AVC | Aortic Valve Disease | 250 | 2028-12-31 | in 865 d | 2026-07-17 |
| Edwards EVOQUE Eos MISCEND StudyNCT02718001Composite of major adverse eventsOpen-label · Treatment | Not applicable | Active, not recruiting | Device: Edwards EVOQUE Eos Mitral Valve Replacement System | Mitral Valve Regurgitation (Degenerative or Functional) | 123 | 2028-04-30 | in 620 d | 2026-04-13 |
| Real-world Clinical Outcomes of the MITRIS RESILIA Mitral ValveNCT05526560observationalFreedom from valve related death or valve related reintervention | — | Active, not recruiting | Device: MITRIS RESILIA Mitral Valve, Model 11400M | Mitral Stenosis, Mitral Valve Insufficiency | 504 | Jan 2028 | ≤ 530 d | 2026-05-22 |
| Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical TrialNCT04097145Composite endpoint including all-cause mortality, RVAD implantation or heart transplant, tricuspid valve intervention, heart failure hospitalizations, and Quality of Life improvement (measured by KCCQ score)Randomized · Open-label · Treatment | Not applicable | Recruiting | Device: Edwards PASCAL System, Edwards PASCAL System, Edwards PASCAL System · Drug: Optimal Medical Therapy | Tricuspid Regurgitation, Tricuspid Valve Insufficiency, Tricuspid Valve Disease | 1,270 | 2027-12-31 | in 499 d | 2026-07-06 |
| TTVR STRONG Under Coverage With Evidence Development (CED) StudyNCT06833476observationalComposite (All-Cause Death or Heart Failure Hospitalization) | — | Recruiting | Other: EVOQUE | Tricuspid Regurgitation | 2,044 | 2027-12-30 | in 498 d | 2025-03-28 |
| Beating Heart Mitral Valve Repair With the HARPOON™ SystemNCT04375332Change in NYHA classification from Baseline to 5 yearsOpen-label · Treatment | Not applicable | Active, not recruiting | Device: HARPOON™ Beating Heart Mitral Valve Repair System | Mitral Regurgitation | 25 | 2027-12-20 | in 488 d | 2026-08-19 |
| Autus Valve Continued Access Study (CAS)NCT07466745Primary Safety EndpointOpen-label · Treatment | Not applicable | Recruiting | Device: Pulmonary Valve Replacement Surgery | Congenital Heart Disease | 36 | 2027-10-30 | in 437 d | 2026-08-10 |
| ALLIANCE: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart ValveNCT05172960Non-hierarchical composite of death and strokeNon-randomized · Open-label · Treatment | Not applicable | Recruiting | Device: SAPIEN X4 THV, SAPIEN X4S | Aortic Stenosis, Severe | 1,234 | Jul 2027 | ≤ 346 d | 2026-08-11 |
| CLAARITY is a Prospective, Observational, Single-arm, Multi-center, Post-market US Study Designed to Evaluate the Safety and Performance of the ECLIPTIS Left Atrial Appendage Exclusion System for Exclusion of the Left Atrial Appendage (LAA) During Concomitant Open-heart Cardiac Surgery.NCT07742839observationalPercentage of participants who have device technical success | — | Not yet recruiting | Device: Edwards ECLIPTIS Left Atrial Appendage Exclusion System | Atrial Appendage | 168 | 2027-07-10 | in 325 d | 2026-08-03 |
| The ENCIRCLE TrialNCT04153292Non-hierarchical composite of death and heart failure rehospitalizationNon-randomized · Open-label · Treatment | Not applicable | Recruiting | Device: SAPIEN M3 valve and dock | Mitral Regurgitation, Mitral Valve Insufficiency | 900 | 2027-02-28 | in 193 d | 2026-02-25 |
| COMPASSION S3 - Evaluation of the SAPIEN 3 Transcatheter Heart Valve in Patients With Pulmonary Valve DysfunctionNCT02744677THV dysfunctionNon-randomized · Open-label · Treatment | Not applicable | Recruiting | Device: SAPIEN 3/SAPIEN 3 Ultra RESILIA THV, SAPIEN 3 THV, SAPIEN 3 Ultra RESILIA THV | Complex Congenital Heart Defect, Dysfunctional RVOT Conduit, Pulmonary Valve Insufficiency, Pulmonary Valve Degeneration | 108 | Dec 2026 | ≤ 134 d | 2026-07-23 |
| Clinical Study of Edwards Cardioband FIT Valve Repair SystemNCT03382457Primary Safety Endpoint -Composite Major Adverse Event (MAE) RateOpen-label · Treatment | Not applicable | Active, not recruiting | Device: Transcatheter Tricuspid Valve Repair | Tricuspid Regurgitation | 75 | 2026-12-31 | in 134 d | 2026-05-08 |
| Real World Data Collection on the INSPIRIS RESILIA Aortic ValveNCT07120048observationalSubject's average mean gradient measurement over time | — | Recruiting | Device: Edwards INSPIRIS RESILIA Aortic Valve | Aortic Valve Disease | 500 | Dec 2026 | ≤ 134 d | 2026-06-22 |
| ALT-FLOW II Trial of the Edwards APTURE Transcatheter Shunt SystemNCT05686317Device + Medical Therapy: Subjects with Early Major Adverse EventsRandomized · Double-masked · Treatment | Not applicable | Active, not recruiting | Device: Edwards APTURE transcatheter shunt system · Diagnostic test: Sham procedure | Heart Failure | 100 | 2026-11-01 | in 74 d | 2026-06-04 |
| Autus Valve Pivotal StudyNCT05006404Valve Implantation Primary Safety EndpointOpen-label · Treatment | Not applicable | Active, not recruiting | Device: Pulmonary Valve Replacement Surgery | Congenital Heart Disease | 51 | 2026-08-01 | — | 2026-07-17 |
| TVMR With the INNOVALVE System Trial - Early Feasibility StudyNCT04919980Absence of implant or delivery related serious adverse events at 30 DaysOpen-label · Treatment | Not applicable | Recruiting | Device: INNOVALVE system | Mitral Valve Regurgitation (Degenerative or Functional) | 65 | 2026-07-01 | — | 2026-05-28 |
| Edwards PASCAL CLASP IID/IIF Pivotal Clinical TrialNCT03706833PASCAL is not inferior to MitraClip with respect to the proportion of patients with major adverse events (MAE). The primary safety endpoint is a composite of Major Adverse Events (MAEs).Randomized · Open-label · Treatment | Not applicable | Active, not recruiting | Device: Edwards PASCAL System, Abbott Mitraclip System | Degenerative Mitral Valve Disease, Mitral Regurgitation, Mitral Insufficiency, Functional Mitral Regurgitation | 1,247 | 2026-06-30 | — | 2026-07-08 |
| TRISCEND II Pivotal TrialNCT04482062Randomized Cohort: Tricuspid Regurgitation (TR) grade reductionRandomized · Open-label · Treatment | Not applicable | Active, not recruiting | Device: Edwards EVOQUE System · Drug: Optimal Medical Therapy | Tricuspid Valve Regurgitation, Tricuspid Valve Insufficiency, Tricuspid Valve Disease, Heart Valve Diseases, Cardiovascular Diseases, Heart Failure | 864 | 2025-12-05actual | — | 2026-02-27 |
| TRISCEND JAPAN StudyNCT05760989All-Cause MortalityOpen-label · Treatment | Not applicable | Active, not recruiting | Device: Edwards EWJ-202 Transcatheter Tricuspid Valve Replacement System | Tricuspid Valve Regurgitation, Heart Valve Diseases, Cardiovascular Diseases | 45 | 2025-09-30 | — | 2024-08-28 |
| ALTERRA Post-Approval StudyNCT05378386observationalAcute Device Success | — | Active, not recruiting | Device: Edwards Alterra Adaptive Prestent with SAPIEN 3 Transcatheter Pulmonary Valve System | Pulmonary Valve Insufficiency, Complex Congenital Heart Defect, Tetralogy of Fallot, Pulmonary Regurgitation, RVOT Anomaly | 150 | 2025-09-25actual | — | 2025-11-04 |
| MiCLASP Post Market Clinical Follow-Up (PMCF) StudyNCT04430075observationalNumber of patients with major adverse events (MAE rates) | — | Active, not recruiting | Device: Edwards PASCAL Transcatheter Valve Repair System and Edwards PASCAL Precision Transcatheter Valve Repair System | Mitral Regurgitation, Mitral Insufficiency | 1,000 | 2025-09-04actual | — | 2026-08-19 |
| TVMR With the Innovalve System Trial - Pilot Study in ItalyNCT05010746Absence of implant or delivery related serious adverse events at 30 daysOpen-label · Treatment | Not applicable | Active, not recruiting | Device: Innovalve TMVR system | Mitral Valve Regurgitation (Degenerative or Functional) | 4 | 2024-05-04actual | — | 2025-06-26 |
| EARLY TAVR: Evaluation of TAVR Compared to Surveillance for Patients With Asymptomatic Severe Aortic StenosisNCT03042104All-cause death, all stroke, and unplanned cardiovascular hospitalizationRandomized · Open-label · Treatment | Not applicable | Active, not recruiting | Device: Edwards SAPIEN 3 / SAPIEN 3 Ultra THV | Heart Diseases, Aortic Stenosis, Severe | 901 | 2024-03-31actual | — | 2024-05-13 |
| 2019-06 TRISCEND StudyNCT04221490results2025-01-09Composite Major Adverse Events (MAEs)Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Not applicable | Active, not recruiting | Device: Transcatheter Tricuspid Valve Replacement | Tricuspid Valve Regurgitation, Heart Valve Diseases, Cardiovascular Diseases | 228 | 2024-01-05actual | — | 2026-05-08 |
| Early Feasibility Study - Edwards APTURE Transcatheter Shunt SystemNCT03523416Rate of major cardiac/cerebrovascular/renal events and re-intervention (Safety Endpoint)Open-label · Treatment | Not applicable | Active, not recruiting | Device: Transcatheter Atrial Shunt System | Heart Failure | 71 | 2023-12-15actual | — | 2025-09-19 |
| Exploratory Study of the Edwards APTURE Transcatheter Shunt System (ALT-FLOW Canada)NCT04000607Rate of major cardiac/cerebrovascular/renal events and re-intervention (Safety Endpoint)Open-label · Treatment | Not applicable | Active, not recruiting | Device: APTURE transcatheter shunt | Heart Failure | 45 | 2023-11-03actual | — | 2026-01-27 |
| Transcatheter Repair of Tricuspid Regurgitation With Edwards PASCAL Transcatheter Valve Repair SystemNCT04614402observationalNumber of patients with major adverse events (MAE rates) | — | Active, not recruiting | Device: Edwards PASCAL Transcatheter Valve Repair System, Edwards PASCAL Precision Transcatheter Valve Repair System | Tricuspid Valve Insufficiency | 300 | 2023-04-20actual | — | 2026-07-16 |
| Transcatheter Repair of Tricuspid Regurgitation With Edwards Cardioband TR System Post Market Study (TriBAND)NCT03779490observationalProcedure Success | — | Active, not recruiting | Device: Transcatheter Tricuspid Valve Repair | Tricuspid Regurgitation, Tricuspid Insufficiency | 150 | 2022-09-30actual | — | 2023-04-06 |
| PARTNER 3 Trial - Mitral Valve in ValveNCT03193801results2023-10-24Safety and Effectiveness - Composite of All-cause Mortality and StrokeOpen-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Not applicable | Active, not recruiting | Device: Edwards SAPIEN 3 transcatheter valve, Model 9600TFX | Mitral Valve Insufficiency, Mitral Valve Disease, Mitral Valve Regurgitation, Heart Failure | 53 | 2022-08-16actual | — | 2025-11-05 |
| ALTERRA: SAPIEN 3 THV With the Alterra Adaptive PrestentNCT03130777results2023-08-08Main Cohort: THV DysfunctionNon-randomized · Open-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Not applicable | Active, not recruiting | Device: Edwards Alterra Adaptive Prestent with SAPIEN 3 THV | Pulmonary Disease, Transcatheter Pulmonary Valve Replacement (TPVR), Tetralogy of Fallot, Congenital Heart Disease, Pulmonary Regurgitation | 86 | 2022-07-14actual | — | 2025-09-25 |
| SAPIEN 3 Ultra System PMCFNCT04555967observationalDevice success per VARC-3, defined as meeting all of the following: | — | Active, not recruiting | Device: SAPIEN 3 Ultra System | Aortic Valve Stenosis | 200 | 2021-09-24actual | — | 2026-04-15 |
| SAPIEN M3 EFS: Early Feasibility Study of the Edwards SAPIEN M3 System for the Treatment of Mitral RegurgitationNCT03230747Technical SuccessOpen-label · Device feasibility | Not applicable | Active, not recruiting | Device: Edwards SAPIEN M3 System | Mitral Regurgitation, Mitral Disease | 72 | 2021-06-16actual | — | 2026-07-17 |
| PARTNER 3 Trial: Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic StenosisNCT02675114results2021-12-02All-cause Mortality, All Stroke, and Rehospitalization (Valve-related or Procedure-related and Including Heart Failure)Randomized · Open-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Not applicable | Active, not recruiting | Procedure: SAVR · Device: SAPIEN 3 THV | Aortic Stenosis | 1,000 | 2020-11-16actual | — | 2026-01-14 |
| ExCEED: CENTERA THV System in Intermediate Risk Patients Who Have Symptomatic, Severe, Calcific, Aortic StenosisNCT03517436results2021-09-30All-cause DeathOpen-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Not applicable | Active, not recruiting | Device: TAVR with CENTERA THV | Aortic Valve Stenosis | 101 | 2020-10-02actual | — | 2025-11-13 |
| A Clinical Trial of Transcatheter Aortic Valves in Dialysis Patients (Japan)NCT02903420results2020-09-24MortalityOpen-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Not applicable | Active, not recruiting | Device: Transcatheter Aortic Valve Implantation (TAVI) | Aortic Stenosis | 38 | 2019-02-14actual | — | 2024-09-25 |
| INSPIRIS RESILIA Aortic Valve, Valve-in-Valve Surveillance StudyNCT04902053observationalSubject's Occurrence Rate of the Composite Safety Endpoint | — | Suspendedsponsor's stated reason: Lack of enrollment. Study will be restarted when there is sufficient INSPIRIS Valve in Valve case volume to support enrollment. | Diagnostic test: Subjects previously implanted with INSPIRIS RESILIA Model 11500A and are undergoing planned valve-in-valve treatment. | Aortic Valve Replacement | 50 | Dec 2030 | ≤ 1,595 d | 2026-08-04 |
| TVMR With the Innovalve System Trial - Pilot in GeorgiaNCT05682066Absence of implant or delivery related serious adverse events at 30 daysOpen-label · Treatment | Not applicable | Completed | Device: Innovalve MR system | Mitral Valve Regurgitation (Degenerative or Functional) | 11 | 2025-01-01actual | — | 2025-04-23 |
| SAPIEN 3 Ultra EU PMSNCT04860752results2025-07-29observationalLength of Index HospitalizationStudy Protocol and Statistical Analysis Plan ↗ | — | Completed | Device: Transcatheter Aortic Valve Implantation (TAVI) | Aortic Stenosis, Aortic Valve Stenosis | 500 | 2024-07-22actual | — | 2025-07-29 |
| HPI (Hypotension Prediction Index) Care TrialNCT05083403results2026-06-10Mean Duration of Hypotension (Defined as MAP < 65mmHg) in Minutes.Randomized · Double-masked · PreventionStudy Protocol and Statistical Analysis Plan ↗ | Not applicable | Terminatedsponsor's stated reason: Trial stopped early for futility | Device: AcumenTM HPI Software Feature · Other: Non-protocolized Standard of Care | Cardiopulmonary Bypass Surgery | 170 | 2024-05-14actual | — | 2026-06-10 |
| ClearSight Baby CuffNCT06834516observationalProper cuff fit | — | Completed | Device: ClearSight baby cuff | Blood Pressure | 15 | 2024-03-11actual | — | 2025-02-19 |
| Magna® Mitral Pericardial Bioprostheses Post-Approval Study ProtocolNCT00853632results2025-05-14Subject's Rate of Objective Performance Criteria Per ISO 5840-2005 - Total Number of Late Adverse Events (by Category) Divided by Late Patient Years (Expressed as a Percentage) for the Magna Mitral Valve Implanted CohortOpen-label · TreatmentStudy Protocol, Statistical Analysis Plan, and Informed Consent Form ↗ | Not applicable | Completed | Device: CEP MAGNA MITRAL PERICARDIAL BIOPROSTHESES | Coronary Artery Disease, Mitral Valve Regurgitation, Mitral Valve Incompetence, Heart Failure | 329 | 2024-03-06actual | — | 2025-05-14 |
| RESILIENCE Trial: Evaluation of the Durability of Aortic Bioprostheses/Valves With RESILIA Tissue in Subjects Under 65NCT03680040observationalTime to bioprosthetic valve failure due to valve deterioration | — | Terminatedsponsor's stated reason: Low enrollment | Diagnostic test: Subjects previously implanted with a RESILIA aortic tissue valve. | Aortic Valve Replacement | 110 | 2024-02-13actual | — | 2024-05-09 |
| Edwards Cardioband European Post-Market Study, MiBANDNCT03600688observationalProcedure Success at discharge | — | Unknown status | Device: Edwards Cardioband System | Mitral Regurgitation, Mitral Insufficiency, Mitral Repair, Mitral Valve, Annuloplasty, Edwards Cardioband | 200 | 2023-12-30 | — | 2023-01-26 |
| ExplorATory Study oF the EdWards Transcatheter Atrial Shunt System (AlT FloW Germany)NCT04965623Rate of Safety Events (MACCREE, Re-Intervention)Open-label · Treatment | Not applicable | Withdrawnsponsor's stated reason: This study was not initiated due to Covid. Then, Edwards Lifesciences elected to withdraw this study due to the initiation of the ALT-FLOW II randomized trial in Germany. | Device: Atrial Shunt | Heart Failure | 0 | 2023-12-06actual | — | 2024-09-19 |
| Pediatric Cardiac Output Monitoring Observational StudyNCT04465370results2024-11-18observationalBias of FloTrac Arterial Pressure Cardiac Output (L/Min) Against Swan Ganz Invasive Cardiac OutputStudy Protocol and Statistical Analysis Plan ↗ | — | Completed | Device: Hemosphere Advanced Monitoring System, ClearSight 1.5, Swan-Ganz Catheter, Flotrac, Foresight | Pediatric ALL | 89 | 2023-01-05actual | — | 2024-11-18 |
| Hypotension Prediction Index (HPI) SMART-BP TrialNCT05105477results2024-03-25A Composite of 30-day Moderate-to-severe Perfusion Related Postoperative Complications.Randomized · Double-masked · PreventionStudy Protocol and Statistical Analysis Plan ↗ | Not applicable | Terminatedsponsor's stated reason: Halted prematurely; voluntarily discontinuation of trial as study specific protocol not followed during data collection | Device: AcumenTM HPI Software Feature · Other: Non-protocolized Standard of Care | Moderate to High-risk Noncardiac Surgery | 407 | 2022-12-15actual | — | 2024-03-25 |
| Observational Registry on the HARPOON DeviceNCT04393779results2024-01-29Freedom From Re-operation Due to Recurrent Severe Mitral Regurgitation Through 1-year Post-implantOpen-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Not applicable | Terminatedsponsor's stated reason: Low enrollment | Device: HARPOON Beating Heart Mitral Valve Repair System (MVRS) | Severe Degenerative Mitral Regurgitation Due to Mid-segment Posterior Leaflet Prolapse | 26 | 2022-11-17actual | — | 2024-01-29 |
| Treatment of Mitral Regurgitation Using a Minimally Invasive Approach With the HARPOON Device.NCT04382612results2023-12-22Percentage of Subject's With Freedom From All-cause Mortality, Disabling Stroke and Life-threatening BleedingOpen-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Not applicable | Terminatedsponsor's stated reason: Low enrollment | Device: HARPOON Beating Heart Mitral Valve Repair System (MVRS) | Mitral Regurgitation | 42 | 2022-11-14actual | — | 2023-12-22 |
| HUDDLE: Heart Health: Understanding & Diagnosing Disease by Leveraging EchocardiogramsNCT05009589observationalAbnormal structural heart findings | — | Completed | — | Cardiovascular Diseases, Heart Diseases | 552 | 2022-10-07actual | — | 2023-01-05 |
| The EU Hyprotect RegistryNCT04972266observationalTo describe the time-weighted average (TWA) mean arterial pressure (MAP) <65 mmHg when using AcumenTM Hypotension Prediction Index software | — | Completed | Device: AcumenTM Hypotension Prediction Index software | Hemodynamic Monitoring | 702 | 2022-09-01actual | — | 2024-12-04 |
| CLEAR Sepsis Clinical StudyNCT03231956observationalComposite outcome | — | Unknown status | Device: ClearSight™ / EV1000NI Clinical Platform | Sepsis | 182 | 2021-12-31 | — | 2020-03-18 |
| TVMR With the Innovalve System Trial - First In Human IsraelNCT05688514Absence of implant or delivery related serious adverse events at 30 daysOpen-label · Treatment | Not applicable | Completed | Device: Innovalve MR system | Mitral Valve Regurgitation (Degenerative or Functional) | 1 | 2021-10-06actual | — | 2025-04-23 |
| COMPASSION XT PAS - Post-approval Study of the SAPIEN XT THV in Patients With Pulmonary Valve DysfunctionNCT02987387observationalFreedom from device- or procedure-related death or reintervention | — | Completed | Device: SAPIEN XT THV | Pulmonary Valve Insufficiency, Pulmonary Valve Stenosis, Heart Defects, Congenital, Congenital Abnormalities, Cardiovascular Diseases, Heart Diseases | 57 | 2021-08-09actual | — | 2025-12-15 |
| Surgical Treatment of Aortic Stenosis With a Next Generation, Rapid Deployment Surgical Aortic ValveNCT01700439results2017-12-13Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the INTUTY Valve Implanted CohortOpen-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Not applicable | Completed | Device: EDWARDS INTUITY valve | Aortic Valve Stenosis, Aortic Valve Stenosis With Insufficiency, Regurgitation, Aortic Valve, Aortic Valve Incompetence | 934 | 2021-05-26actual | — | 2023-05-19 |
| Edwards CLASP TR EFSNCT03745313results2024-10-09Composite Major Adverse Event (MAE) RateOpen-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Not applicable | Completed | Device: Edwards PASCAL Transcatheter Valve Repair System | Tricuspid Regurgitation | 65 | 2021-05-11actual | — | 2026-07-10 |
| Edwards PASCAL Transcatheter Valve Repair System RegistryNCT04443218results2024-07-26observationalMajor Adverse Events (MAEs)Study Protocol ↗ · Statistical Analysis Plan ↗ | — | Completed | Device: Edwards PASCAL Transcatheter Valve Repair System | Mitral Valve Insufficiency | 220 | 2021-05-10actual | — | 2024-07-26 |
| The CLASP Study Edwards PASCAL TrAnScatheter Mitral Valve RePair System StudyNCT03170349results2021-12-01Number of Participants With Major Adverse Events (MAE)Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Not applicable | Completed | Device: Mitral Valve Repair | Mitral Valve Regurgitation | 124 | 2020-07-30actual | — | 2026-02-05 |
| Hypotension Prediction Index Study (HPI Study)NCT03805217observationalReduction of Intraoperative Hypotension | — | Completed | Device: EV1000A Clinical Platform with Acumen Hypotension Prediction Index Feature Software | Hypotension | 485 | 2020-03-17actual | — | 2024-10-18 |
| The SAPIEN 3 Ultra System in Intermediate Risk Patients With Symptomatic, Severe Aortic StenosisNCT03471065results2021-01-19Procedural SuccessOpen-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Not applicable | Completed | Device: SAPIEN 3 Ultra Delivery System with the SAPIEN 3 Ultra THV | Aortic Valve Stenosis | 100 | 2019-12-23actual | — | 2025-05-18 |
| CardiAQ-Edwards™ Transcatheter Mitral Valve Replacement (TMVR) StudyNCT02722551Freedom from major adverse cardiac and cerebrovascular eventsOpen-label · Treatment | Phase 1/2 | Withdrawn | Device: Transcatheter Mitral Valve Re-placement (TMVR) with the CardiAQ-Edwards™ Transcatheter Mitral Valve | Mitral Valve Regurgitation | 0 | Oct 2019 | — | 2018-01-09 |
| ClearSight System CHN StudyNCT03807622observationalCardiac Output using the Non-invasive ClearSight System | — | Completed | Device: EV1000NI Clinical Platform: Noninvasive Hemodynamic Monitoring utilizing ClearSight System | Patient With Clinically Indicated Invasive Monitoring | 125 | 2019-10-17actual | — | 2019-11-12 |
| CENTERA PMCF: Post-Market Follow-up of the CENTERA Transcatheter Heart Valve SystemNCT03699345observationalAll-Cause Mortality | — | Completed | Device: Transcatheter Aortic Valve Replacement (TAVR) | Aortic Valve Stenosis | 87 | 2019-08-14actual | — | 2024-11-04 |
| Edwards Cardioband System ACTIVE Pivotal Clinical Trial (ACTIVE)NCT03016975results2022-11-09Prevalence of MR ≤ 2+ and Hierarchical Comparison of Randomized Device and Randomized Control Groups [Cardiovascular Death, Number of Heart Failure Hospitalizations, Improvement in 6 MWT Distance (in Meters) and KCCQ (Number of Points Improved)].Randomized · Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Not applicable | Terminatedsponsor's stated reason: Procedure and device development | Device: Edwards Cardioband System · Drug: Guideline Directed Medical Therapy | Functional Mitral Regurgitation, Mitral Regurgitation, Mitral Insufficiency | 12 | 2019-07-19actual | — | 2023-11-30 |
| China S3: Safety and Effectiveness of Edwards Lifesciences SAPIEN 3 THV in the Chinese PopulationNCT03466918results2020-07-15All-cause MortalityOpen-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Not applicable | Completed | Device: SAPIEN 3 THV with the Commander delivery system | Aortic Stenosis, Symptomatic Aortic Stenosis, Aortic Regurgitation | 58 | 2019-07-03actual | — | 2025-09-10 |
| Early Feasibility Study of the Edwards FORMA Tricuspid Transcatheter Repair SystemNCT02471807results2022-01-06Major Adverse Event Rate : Count and Percentage of Patients Who Experienced at Least One MAEOpen-label · TreatmentStudy Protocol: Rev K ↗ · Study Protocol: Rev M ↗ · Statistical Analysis Plan ↗ | Not applicable | Completed | Device: Edwards FORMA Tricuspid Transcatheter Repair System | Tricuspid Valve Regurgitation | 34 | Jun 2019actual | — | 2023-03-28 |
| Assisted Fluid Management IDE StudyNCT03469570results2024-11-08Effectiveness of the Assisted Fluid Management FeatureOpen-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Not applicable | Completed | Device: EV1000 Clinical Platform with Assisted Fluid Management (AFM) Feature | Non-Cardiac/ Non-Thoracic Surgery, Abdominal Surgery, Pelvic Surgery, Major Peripheral Vascular Surgery | 330 | 2018-12-21actual | — | 2024-11-08 |
| Magna Mitral - 23mmNCT01312779results2020-03-03Percent of Early Adverse Events DividedOpen-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Not applicable | Completed | Device: Implantation of CEP Magna Mitral Model 7000TFX | Mitral Heart Valve Disease | 39 | Nov 2018actual | — | 2020-03-18 |
| Carpentier-Edwards PERIMOUNT Magna Ease Pericardial Bioprosthesis, Model 3300TFXNCT01171625results2020-04-17Subject's Percentage of Long Term Safety PerformanceOpen-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Not applicable | Completed | Device: Implantation of CEP Magna Ease Model 3300TFX | Coronary Artery Disease, Aortic Valve Disorder, Heart Failure, Aortic Valve Stenosis, Aortic Valve Insufficiency | 283 | Sep 2018actual | — | 2020-04-17 |
| COMMENCE Pulmonary: Clinical Evaluation of Edwards Pericardial Aortic Bioprosthesis (Model 11000A) for Pulmonary Valve ReplacementNCT02656290results2020-03-17Percentage of Subject's With Freedom From Device or Procedure Related Death and/or Reoperation at 1-year Post-implant.Open-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Not applicable | Completed | Device: Edwards Pericardial Aortic Bioprosthesis Model 11000A | Pulmonary Valve Insufficiency, Pulmonary Valve Degeneration, Congenital Pulmonary Valve Abnormality | 26 | Sep 2018actual | — | 2023-11-21 |
| Clinical Trial of the Edwards Aortic Bioprosthesis, Model 11000NCT01651052results2019-07-26Number of Early Adverse Events Divided by Number of Subjects (Expressed as a Percentage)Open-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Not applicable | Completed | Procedure: Heart Valve Surgery | Aortic Valve Disorder, Aortic Valve Insufficiency, Aortic Valve Stenosis, Heart Failure, Coronary Artery Disease | 133 | Jul 2018actual | — | 2019-07-26 |
| China XT: Safety and Effectiveness of Edwards Lifesciences SAPIEN XT THV in the Chinese PopulationNCT03314857results2020-07-15All-cause MortalityOpen-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Not applicable | Completed | Device: SAPIEN XT THV with the NovaFlex+ delivery system | Aortic Stenosis, Symptomatic Aortic Stenosis, Aortic Regurgitation | 67 | 2018-07-06actual | — | 2023-09-05 |
| CE Mark Study for the Harpoon Medical Device in PolandNCT02432196results2019-11-25Subject's Procedural Success During the First 30 DaysOpen-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Not applicable | Completed | Device: Harpoon Medical Device | Mitral Valve Regurgitation, Mitral Valve Prolapse, Mitral Valve Insufficiency | 26 | 2018-02-08actual | — | 2024-01-22 |
| The SPACER Trial - Repair of Tricuspid Valve Regurgitation Using the Edwards TricuSPid TrAnsCatheter REpaiR SystemNCT02787408results2022-10-25All-cause MortalityOpen-label · TreatmentStudy Protocol: Revision A.G.3 ↗ · Study Protocol: Revision C ↗ · Statistical Analysis Plan ↗ | Not applicable | Completed | Device: EW Tricuspid Transcatheter Repair System | Tricuspid Valve Regurgitation | 25 | 2018-01-30actual | — | 2022-10-25 |
| TRI-REPAIR: TrIcuspid Regurgitation RePAIr With CaRdioband Transcatheter SystemNCT02981953results2021-06-28Major Serious Adverse Events (MSAEs) and Serious Adverse Device Effects (SADE)Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Not applicable | Completed | Device: Cardioband Tricuspid | Tricuspid Valve Insufficiency, Tricuspid Regurgitation, Tricuspid Valve Regurgitation, Cardiovascular Diseases, Heart Valve Diseases, Heart Diseases, Cardiac Valve Annuloplasty | 40 | 2018-01-01actual | — | 2021-06-28 |
| Surgical Treatment of Aortic Stenosis With a Next Generation Surgical Aortic ValveNCT01445171results2020-02-17Percent of Early Adverse EventsOpen-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Not applicable | Completed | Device: Aortic Valve Replacement with EDWARDS INTUITY Valve System | Aortic Valve Stenosis With Insufficiency, Aortic Valve Stenosis | 295 | Dec 2017actual | — | 2023-09-01 |
| REPAIR - transcatheteR rEPair of mitrAl Insufficiency With caRdioband SystemNCT02703311results2020-11-09Reduction in Severity of MR at 30 Days of at Least One Category on a 0-4 Scale.Open-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Not applicable | Terminatedsponsor's stated reason: Edwards acquired Valtech Cardio Ltd in 2017 and opted to replace this study with NCT03600688.11 patients were enrolled in REPAIR and follow-up is complete. | Device: Cardioband | Mitral Valve Insufficiency, Cardiac Valve Annuloplasty, Mitral Valve Annuloplasty, Cardiovascular Diseases, Heart Diseases, Heart Valve Diseases, Mitral Regurgitation | 11 | Nov 2017actual | — | 2020-11-09 |
| CE Mark Study for the Harpoon Medical DeviceNCT02768870results2019-11-25Subject's Procedural Success During the First 30 DaysOpen-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Not applicable | Completed | Device: Harpoon Artificial ePTFE Chords | Mitral Valve Regurgitation, Mitral Valve Prolapse, Mitral Valve Insufficiency | 26 | 2017-11-06actual | — | 2024-01-11 |
| PARTNER II Trial: S3iCAPNCT02687035results2021-04-08DeathOpen-label · TreatmentStudy Protocol ↗ | Not applicable | Completed | Device: SAPIEN S3 valve | Aortic Stenosis | 1,822 | Oct 2017actual | — | 2021-04-08 |
| ProspeCtive, nOn-randoMized, MulticENter Clinical Evaluation of Edwards Pericardial Bioprostheses With a New Tissue Treatment Platform (COMMENCE)NCT01757665results2019-12-27Subjects With Structural Valve DeteriorationOpen-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Not applicable | Completed | Device: Edwards Aortic and Mitral Bioprostheses Models 11000A and 11000M | Aortic Stenosis, Mitral Stenosis, Aortic Valve Insufficiency, Mitral Valve Insufficiency, Heart Failure | 777 | Aug 2017actual | — | 2026-05-07 |
| Safety and Performance Study of the Harpoon Mitral Valve Repair SystemNCT03285724results2019-10-14Number of Subjects With Procedural Success During the First 30 DaysOpen-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Not applicable | Terminatedsponsor's stated reason: Edwards Lifesciences acquired Harpoon Medical in December 2017 and a decision has been made to close enrollment in the HMEFS-2000 protocol | Device: Harpoon Artificial ePTFE Chords | Mitral Valve Regurgitation, Mitral Valve Prolapse, Mitral Valve Insufficiency | 1 | 2017-06-16actual | — | 2019-11-19 |
| EDWARDS INTUITY Elite Valve SystemNCT02907463results2019-11-08observationalSubject's Average Time Spent on Cardiopulmonary Cross ClampStudy Protocol, Statistical Analysis Plan, and Informed Consent Form ↗ | — | Completed | — | Aortic Valve Disease, Aortic Stenosis | 280 | Apr 2017actual | — | 2019-11-22 |
| Clinical Study to Evaluate the Performance of Magna Ease Heart Valve in Chinese PatientsNCT02523066observationalEchocardiography to evaluate the performance of heart valve | — | Terminatedsponsor's stated reason: Sponsor decision | Device: Magna Ease | Mitral Valve or Aortic Valve Replacement | 215 | 2017-04-29actual | — | 2025-05-18 |
| PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - Nested Registry 3/Valve-in-ValveNCT03225001results2018-01-09Number of Participants With All-Cause Mortality, All Stroke, Moderate or Severe Obstruction, or Moderate or Severe Paravalvular Leak (Composite)Open-label · Treatment | Not applicable | Completed | Device: Edwards SAPIEN XT transcatheter valve, Model 9300TFX | Aortic Stenosis, Cardiomyopathy, Hypertrophic | 197 | 2016-12-16actual | — | 2021-03-09 |
| Cardioband With Transfemoral Delivery SystemNCT01841554results2020-03-11Number of Participants With Major Serious Adverse Events and Serious Adverse Device EffectsOpen-label · Treatment | Not applicable | Completed | Device: Cardioband | Mitral Regurgitation | 62 | Aug 2016actual | — | 2020-11-30 |
| Early Feasibility Study of the CardiAQ™ TMVI System (Transfemoral and Transapical DS)NCT02515539Composite Major Adverse Event RateOpen-label · Treatment | Not applicable | Withdrawnsponsor's stated reason: Edwards Lifesciences terminated the IDE associated with this study. No patients enrolled. | Device: CardiAQ TMVI System (Transapical & Transfemoral DS) | Mitral Insufficiency, Heart Valve Disease, Cardiovascular Disease, Heart Disease | 0 | Aug 2016 | — | 2016-03-31 |
| CENTERA-2: Safety and Performance Study of the Edwards CENTERA-EU Self-Expanding Transcatheter Heart ValveNCT02458560All-cause mortality rateOpen-label · Treatment | Not applicable | Completed | Device: Edwards CENTERA Self-Expanding Transcatheter Heart Valve | Aortic Valve Disease | 203 | 2016-08-22actual | — | 2021-10-18 |
| MITRAFIT- Cardinal Adjustable Mitral Repair Follow-up International Postmarketing Surveillance (PMS)NCT01617720observational• Ability of the Cardinal ring to reduce mitral valve regurgitation | — | Completed | — | Mitral Regurgitation | 45 | Jun 2016actual | — | 2021-11-05 |
| EDWARDS INTUITY Valve System FOUNDATION StudyNCT02338154results2019-10-14observationalSubject's Average Time Spent on Cardiopulmonary Cross Clamp | — | Completed | — | Aortic Valve Disease, Aortic Stenosis, Rapid Deployment Valves | 516 | Apr 2016actual | — | 2019-11-22 |
| EDWARDS INTUITY Valve System CADENCE StudyNCT02688153results2018-06-01Average Subject Time Spent on Cardiopulmonary Cross ClampRandomized · Open-label · Treatment | Not applicable | Completed | Device: EDWARDS INTUITY, Stented aortic bioprostheses | Aortic Valve Disease, Aortic Stenosis | 120 | Apr 2016actual | — | 2018-06-01 |
| Clinical Study to Evaluate the Performance of Perimount Heart Valve in Chinese PatientsNCT02400489observationalTwice echocardiography to evaluate the performance of heart valve | — | Completed | — | Mitral Valve or Aortic Valve Replacement | 265 | 2016-04-27actual | — | 2022-03-18 |
| Safety and Early Feasibility Study of the Harpoon Medical Device (EFS)NCT02771275results2019-11-25Number of Subjects With Procedural Success During the First 30 DaysOpen-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Not applicable | Completed | Device: Harpoon Medical Device | Mitral Valve Regurgitation, Mitral Valve Prolapse, Mitral Valve Insufficiency | 13 | 2016-03-21actual | — | 2024-01-22 |
| The SOLACE-AU Clinical TrialNCT01675596results2019-04-16VARC-2 Composite Safety EndpointOpen-label · Treatment | Not applicable | Completed | Device: TAVR Implantation of the Transcatheter Aortic Valve Prosthesis | Severe, Symptomatic Aortic Stenosis | 199 | Feb 2016actual | — | 2019-04-16 |
| SOURCE 3: Observational Study to Evaluate Safety and Performance of SAPIEN 3 THV System in Real Life PracticeNCT02698956observationalAll cause mortality | — | Completed | Device: TAVI (Transcatheter Aortic Valve Implantation) | Aortic Stenosis | 2,000 | Feb 2016actual | — | 2021-03-16 |
| PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - XT Intermediate and High RiskNCT01314313results2018-08-14All-cause Death or Disabling Stroke to Two YearsRandomized · Open-label · Treatment | Not applicable | Completed | Device: TAVR Implantation with SAPIEN XT, SAVR Implantation | Symptomatic Severe Aortic Stenosis | 2,032 | Jan 2016actual | — | 2024-03-07 |
| GlucoClear ICU StudyNCT02238041observational15/20% Accuracy | — | Withdrawnsponsor's stated reason: Discontinued program | Device: GlucoClear System | Intensive Care Unit Blood Glucose Monitoring | 0 | Dec 2015 | — | 2015-10-01 |
| COMPASSION - COngenital Multicenter Trial of Pulmonic VAlve Regurgitation Studying the SAPIEN InterventIONal THVNCT00676689results2016-09-01Freedom From Device or Procedure Related Death or ReinterventionOpen-label · Treatment | Not applicable | Completed | Device: SAPIEN Transcatheter Valve Implantation | Pulmonary Valve Insufficiency, Pulmonary Regurgitation, Dysfunctional RVOT Conduit, Pulmonary Obstruction, Pulmonary Stenosis | 81 | Nov 2015actual | — | 2020-02-26 |
| PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - S3 IntermediateNCT03222128results2018-08-14Number of Participants With Composite of All-cause Death, All Stroke and Aortic Insufficiency (AI) ≥ ModerateOpen-label · Treatment | Not applicable | Completed | Device: TAVR | Symptomatic Severe Aortic Stenosis | 1,074 | 2015-11-18actual | — | 2025-01-03 |
| PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - High Risk and Nested Registry 7NCT03222141results2018-08-14The Composite Rate of All-cause Mortality, All Stroke, and AI ≥ ModerateOpen-label · Treatment | Not applicable | Completed | Device: TAVR Implantation of the THV Prosthesis | Symptomatic Severe Aortic Stenosis | 583 | Sep 2015actual | — | 2021-05-12 |
| A Clinical Study of the CardiAQ™ TMVI System (Transapical DS)NCT02478008Composite Major Adverse Event RateOpen-label · Treatment | Not applicable | Terminatedsponsor's stated reason: Edwards acquired CardiAQ and opted to terminate this study. 2 patients were enrolled and follow-up is complete. No further enrollment or follow-up will occur. | Device: CardiAQ TMVI System (Transapical DS) | Mitral Insufficiency, Heart Valve Disease, Cardiovascular Disease, Heart Disease | 2 | Aug 2015actual | — | 2016-03-31 |
| EDWARDS INTUITY Valve System CADENCE-MIS StudyNCT02672553results2019-01-28Median Subject Time Spent on Cardiopulmonary Cross ClampRandomized · Open-label · Treatment | Not applicable | Completed | Device: EDWARDS INTUITY Valve System, Model 8300A, Stented Aortic Bioprostheses | Aortic Valve Disease, Aortic Stenosis | 100 | Mar 2015actual | — | 2019-01-28 |
| SOURCE XT REGISTRYNCT01238497observationalAssess and track causality and sequelae of major adverse events | — | Completed | Device: TAVR Implantation of the Transcatheter Aortic Valve Prosthesis, TAVR Implantation of the Transcatheter Aortic Valve Prosthesis, TAVR Implantation of the Transcatheter Aortic Valve Prosthesis | Severe Aortic Stenosis | 2,954 | Aug 2014actual | — | 2020-08-28 |
| Safety and Performance Study of the Edwards SAPIEN 3 Transcatheter Heart Valve/ The SAPIEN 3 StudyNCT01808287All-cause mortality rateNon-randomized · Open-label · Treatment | Not applicable | Completed | Device: Edwards SAPIEN 3 Transcatheter Heart Valve | Aortic Valve Disease | 250 | Dec 2013actual | — | 2020-04-01 |
| GlucoClearTM System ICU StudyNCT02094859observational15/20% Performance | — | Completed | — | Accurate Blood Glucose Monitoring in Critical Care Setting | 50 | Sep 2013actual | — | 2014-03-24 |
| Safety and Performance Study of the Edwards CENTERA Self-Expanding Transcatheter Heart ValveNCT01808274All-cause mortality rateOpen-label · Treatment | Not applicable | Completed | Device: Edwards CENTERA Self-Expanding Transcatheter Heart Valve | Aortic Valve Disease | 34 | 2013-09-17actual | — | 2018-11-20 |
| Pulmonic Valve REplacement Multi-discIpline EMEA RegistryNCT01356108observationalSafety | — | Completed | Device: Transcatheter Pulmonic Valve Replacement (TPVR) (Edwards SAPIEN™ THV) | Pulmonary Regurgitation, Pulmonary Insufficiency, Pulmonary Stenosis | 127 | Jul 2013actual | — | 2018-11-20 |
| The PARTNER II Trial: Placement of AoRTic TraNscathetER Valves - PII BNCT02184442results2018-08-14Number of Participants With All-Cause Mortality and/or Major Stroke and/or RehospitalizationRandomized · Open-label · Treatment | Not applicable | Completed | Device: TAVR Implantation with SAPIEN XT, TAVR Implantation with SAPIEN | Severe, Symptomatic, Calcific Aortic Stenosis | 560 | 2013-05-01actual | — | 2018-09-25 |
| PREVAIL-20J - Transfemoral Placement of 20mm Aortic Balloon Expandable Transcatheter Valve TrialNCT01419015results2020-08-06NYHA Improvement and AVA >= 0.65 cm2Open-label · Treatment | Not applicable | Completed | Device: SAPIEN XT NovaFlex delivery system | Aortic Valve Stenosis | 17 | Jan 2013actual | — | 2020-08-06 |
| V-Chordal Adjustable System for Chordal Replacement in Mitral Valve Insufficiency Due to Leaflet ProlapseNCT01415947Technical success rateNon-randomized · Open-label · Treatment | Phase 2 | Terminatedsponsor's stated reason: Company business decision | Device: V Chordal | Mitral Leaflet Prolapse | 5 | May 2012actual | — | 2014-12-23 |
| CARDINAL Adjustable Annuloplasty Ring System For Treatment of Mitral RegurgitationNCT01137734Percentage of Subjects with Valtech Cardinal Mitral Heart Valve Device Technical SuccessOpen-label · Treatment | Not applicable | Completed | Device: Adjustable Annuloplasty Ring with option to adjust off pump., Device: Adjustable Annuloplasty Ring (with option to adjust off-pump) | Mitral Valve Insufficiency | 30 | Feb 2012actual | — | 2021-11-05 |
| PREVAIL-J - Transfemoral & Transapical Placement of Aortic Balloon Expandable Transcatheter Valves Trial (Japan)NCT01113983results2020-05-01Improvement of the AVA and NYHA Functional ClassificationOpen-label · Treatment | Not applicable | Completed | Device: Transcatheter aortic valve implantation | Aortic Valve Stenosis | 64 | Oct 2011actual | — | 2020-05-01 |
| PREVAIL-TA: Placement of Aortic Balloon Expandable Transcatheter Valves Trial (Europe)NCT01238835results2020-11-02Number of DeathsOpen-label · Treatment | Not applicable | Completed | Device: SAPIEN XT™ Transapical aortic valve replacement | Aortic Valve Stenosis | 220 | Feb 2011actual | — | 2020-11-02 |
| PREVAIL-TF: Transfemoral Placement of Aortic Balloon Expandable Transcatheter Valves Trial (Europe)NCT00820599results2020-11-02Number of DeathsOpen-label · Treatment | Not applicable | Completed | Device: Sapien XT™ transcatheter heart valve and delivery system | Aortic Valve Stenosis | 214 | Dec 2010actual | — | 2020-11-02 |
| Clinical Evaluation of a New Transpulmonary Thermodilution Method to Assess Thermodilution Cardiac Output, Global End Diastolic Volume and Extravascular Lung WaterNCT01405040observationalTPTD, GEDV and EVLW measurements to evaluate the precision and accuracy of a novel algorithm in comparison to the widely accepted TPTD method | — | Completed | — | Cardiac Output and Preload Assessment, Lung Water Assessment | 97 | Dec 2010actual | — | 2013-04-04 |
| THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve TrialNCT00530894results2017-05-11DeathRandomized · Open-label · Treatment | Not applicable | Completed | Device: Edwards SAPIEN Transcatheter Heart Valve, Surgical Valve Replacement · Other: medical management and/or balloon aortic valvuloplasty | Critical Aortic Stenosis | 1,057 | Sep 2010actual | — | 2017-09-13 |
| Clinical Study of the Intravenous Blood Glucose System in Hospitalized Adult Elective or Non-Emergent Surgery and Medical/Surgical Intensive Care Unit PatientsNCT00906490observationalA non-inferior design to demonstrate that the IVBG System is equivalent (non-inferior) to a POC meter with respect to the proportion of glucose measurements that are deemed acceptable using a metric defined in ISO 15197. | — | Completed | Device: Intravenous Blood Glucose monitoring system | Blood Glucose | 100 | Apr 2010actual | — | 2013-08-20 |
| Using Minimally Invasive Cardiac Output Data vs. Standard Care for Patients Emergently Admitted to the Intensive Care Unit Who Are Hemodynamically UnstableNCT00354211observational | — | Completed | Device: minimally invasive cardiac output system consisting of arterial line sensor and cardiac output bedside monitor (device) | Cardiac Output, High, Cardiac Output, Low | 392 | Sep 2007actual | — | 2013-02-11 |
Primary completion is the date the sponsor filed with the registry — their own projection, revised whenever they revise it, unless the row is marked actual.
Source: ClinicalTrials.gov, retrieved 2026-08-19