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Clinical trials
catalyst calendar across sponsors →Studies where LIVN 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.
25 interventional · 15 observational · 2 with posted results
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| Study | Phase | Status | Interventions | Conditions | Enrollment | Primary completion | Readout in | Updated |
|---|---|---|---|---|---|---|---|---|
| A Study to Assess Effectiveness and Efficiency of VNS Therapy in Patients With Difficult to Treat Depression.NCT03320304observationalThe primary endpoint of this study is response defined as reduction in Montgomery Åsberg Depression Rating Scale (MADRS) total score of at least 50% from baseline to 12 months post implant. | — | Recruiting | Device: Vagal Nerve Simulation (VNS) Therapy | Treatment Resistant Depression | 500 | 2029-12-01 | in 1,199 d | 2026-01-26 |
| A Prospective, Multi-center, Randomized Controlled Blinded Trial Demonstrating the Safety and Effectiveness of VNS Therapy® System as Adjunctive Therapy Versus a No Stimulation Control in Subjects With Treatment-Resistant DepressionNCT03887715Montgomery Åsberg Depression Rating Scale (MADRS) Rate of ResponseRandomized · Quadruple-masked · Treatment | Not applicable | Recruiting | Device: Vagus Nerve Stimulation (VNS) | Treatment Resistant Depression | 6,800 | 2028-02-28 | in 557 d | 2026-06-15 |
| Non-interventional Study Describing Healthcare Resource Utilisation and Clinical Outcomes Associated With VNS Therapy in UK.NCT04779814observationalChange in hospital resource utilization | — | Terminatedsponsor's stated reason: The study was terminated by the sponsor due to persistent delays in recruitment and data availability, including access to the healthcare resource utilization database, which made it difficult to generate meaningful outcomes. | — | Epilepsy | 97 | 2025-08-19actual | — | 2026-03-25 |
| Treating Obstructive Sleep Apnea Using Targeted Hypoglossal NeurostimulationNCT04950894Rate of response to therapy when compared to no therapy for 6 monthsRandomized · Double-masked · Treatment | Not applicable | Completed | Device: Hypoglossal Nerve Stimulation | Obstructive Sleep Apnea, OSA, Apnea, Apnea, Obstructive, Apnea, Obstructive Sleep, Apnea+Hypopnea, Hypopnea, Sleep | 107 | 2024-10-17actual | — | 2026-07-17 |
| Registry of Subjects With Drug Resistant Epilepsy and Treated With the VNS Therapy System.NCT03529045observationalSeizure Frequency | — | Completed | Device: Vagus Nerve Stimulation (VNS) Therapy | Epilepsy, Seizures, Drug Resistant Epilepsy | 827 | 2024-09-11actual | — | 2024-11-22 |
| The RECOVER sUb-study, Which Leverages quaNtitative and Credible Research tOols From Verily, Will providE Assessment measuRes for Depressive EpisodesNCT04753385observationalPercentage of PHQ-8 tasks | — | Terminatedsponsor's stated reason: UNCOVER terminated early based on low enrollment and lack of device data collected making analysis unfeasible. | — | Treatment Resistant Depression | 138 | 2024-09-06actual | — | 2024-12-20 |
| IMPACT of AspireSR® for VNS Therapy on Healthcare Resource Utilisation and Clinical Outcomes.NCT05975931observationalDescriptive comparison of healthcare resource use (HCRU) | — | Terminatedsponsor's stated reason: The decision to terminate was taken based on study team capacity not sufficient and alignment with the sponsor. | — | Epilepsy | 15 | 2024-01-30actual | — | 2024-12-03 |
| ANTHEM-HFrEF Pivotal StudyNCT03425422Event-free rateRandomized · Open-label · Treatment | Not applicable | Terminatedsponsor's stated reason: Company decision to stop enrolling not associated with any safety concerns. | Device: VITARIA System | Heart Failure, Heart Failure, Congestive, Heart Failure, Systolic | 533 | 2023-05-31actual | — | 2023-10-10 |
| XLTCS - Accelerometer Data Collection in an Epilepsy Monitoring Unit (EMU)NCT04282681observationalEvaluate accelerometer data and tonic-clonic seizure data | — | Withdrawnsponsor's stated reason: Sponsor decision due to clinical strategy changes | Other: Accelerometer Live-Streaming Tool | Epilepsy, Tonic-Clonic | 0 | 2021-08-28 | — | 2020-08-25 |
| Microburst Vagus Nerve Stimulator (VNS) Therapy Feasibility StudyNCT03446664Efficacy Primary Endpoint: Percent change from baseline in seizure frequencyOpen-label · Treatment | Not applicable | Completed | Device: Microburst Stimulation | Epilepsies, Partial, Epilepsy, Tonic-Clonic | 33 | 2021-07-30actual | — | 2022-10-25 |
| Mitroflow DL Post Approval Study- North AmericaNCT02351726Rate of structural Valve Deterioration in Implanted PatientsOpen-label · Treatment | Not applicable | Terminatedsponsor's stated reason: Sponsor business decision | Device: Mitroflow DL | Aortic Stenosis, Aortic Regurgitation, Aortic Valve Insufficiency, Heart Valve Diseases, Cardiovascular Abnormalities, Cardiovascular Diseases, Congenital Abnormalities, Heart Diseases, Pathological Conditions, Anatomical | 186 | 2019-12-31actual | — | 2020-02-20 |
| Sleep Apnea, Arrhythmias and Cardiac Reverse Remodeling in Heart Failure PatientsNCT02870647The change in severity of SBD (by means of AHI as determined by PG), in the responders to CRT (reverse remodeling, delta LVESV=>15%) compared to the non-responders, at 6-month follow-up after implant (de-novo or upgrade).Open-label · Diagnostic | Phase 4 | Withdrawnsponsor's stated reason: Strategy changes. | Other: Echocardiographic, polygraphy, electrocardiography measurements and sleep questionnaire | Sleep Breathing Disorders in the Responders to Cardiac Resynchronisation Therapy (CRT) | 0 | Jun 2019 | — | 2017-11-14 |
| PErsonalized and Adaptive Kinesthetic stImulation Therapy, Based on Cardio-respiratory Holter moNitoring, for Sleep Apnea syndrOmesNCT02789748Rate of responder to the therapyRandomized · Single-masked · Treatment | Not applicable | Completed | Device: Kinesthetic stimulation | Obstructive Sleep Apnea Syndrome | 42 | 2017-10-02actual | — | 2017-10-05 |
| Clinical Evaluation of LEft VEntricular Auto Threshold Algorithm (LEVEA)NCT03014180results2019-05-28Percentage of Successful"In-Clinic LVAT" TestOpen-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Not applicable | Completed | Device: "In-Clinic LVAT" | Heart Failure | 60 | 2017-08-17actual | — | 2019-05-28 |
| Optimization With SonR Method in the ClinicAl pRacticeNCT02250547observationalevaluate the percentage of patients optimized at least once every month by the SonR automatic optimization method, until M6 follow-up, in HF patients prevalently in sinus rhythm | — | Completed | — | CRT Patients | 278 | Jan 2017actual | — | 2017-11-14 |
| The remedē® System for the Treatment of Central Sleep Apnea in Daily PracticeNCT02577445results2017-04-06observationalIncidence of All Cause Mortality, SAEs, Stimulation Complaints, Device and/or Cardiovascular Related Events From Implant up to 5 Years. | — | Terminatedsponsor's stated reason: Commercial distribution of the remedē System stopped by LivaNova. | — | Sleep Apnea, Central Sleep Disordered Breathing | 31 | Oct 2016actual | — | 2017-04-06 |
| VAgal Nerve Stimulation: safeGUARDing Heart Failure PatientsNCT02113033The primary outcome measure is the freedom from Serious Adverse Device Effects, defined as the number of patients without SADEs.Open-label · Treatment | Phase 2 | Completed | Device: Equilia® Vagal Nerve Stimulation | Heart Failure With Reduced Ejection Fraction | 15 | 2016-02-22actual | — | 2018-03-13 |
| Left Ventricular Pacing Vectors Effectiveness to Narrow Phrenic Nerve StimulationNCT03127202Phrenic nerve stimulation measurementOpen-label · Prevention | Not applicable | Completed | Device: Cardiac Resynchronization Therapy -Defibrillator (range PARADYM, LivaNova, Clamart, France) | Heart Failure | 90 | Dec 2015actual | — | 2017-04-25 |
| Evolution of the PR Interval in Patients Implanted With a Pacemaker Using the SafeR ModeNCT02586480observationalProlonged PR interval (> 200ms) in patients without AVB I at baseline (Incidence of "clinical" AVB1) | — | Completed | Device: dual chamber pacemaker with SafeR algorithm | Sinus Node Dysfunction, Atrioventricular Block | 848 | Nov 2015actual | — | 2017-10-18 |
| HYpopnea and Apnea Detection and Treatment Performance of a New cardiOreSpiratory Holter MonitorNCT03300037observationalPerformance of real-time detector of apnea and hypopnea: sensitivity and positive predictive value of the detector will be calculated when comparing automatically detected respiratory events to gold-standard PSG scoring of apnea/hypopnea events. | — | Completed | Device: Kinesthetic stimulation | Sleep Apnea, Obstructive | 46 | 2015-04-16actual | — | 2017-10-03 |
| An Observational Study on the Sorin Group New Brady Leads XFine and BeflexNCT01168518observationalLead dislodgment rate in acute phase | — | Completed | — | Pacing Leads Implantation | 2,254 | Sep 2014actual | — | 2014-09-29 |
| Clinical Evaluation of the Physiological Diagnosis Function in the PARADYM CRT DeviceNCT02167789Number of HF related eventsOpen-label · Diagnostic | Phase 3 | Completed | Device: Paradym CRT 8770 | Heart Failure | 520 | Jun 2013actual | — | 2014-06-19 |
| Monitoring of Syncopes and/or Sustained Palpitations of Suspected Arrhythmic Origin With External Loop-Recorder (SpiderFLASH)NCT02253134observationalEvaluate the mean value of the diagnostic yield in one month | — | Completed | — | Syncope, Palpitations | 395 | Jun 2013actual | — | 2014-10-01 |
| Clinical Evaluation of the Sorin Group's REPLY MR-conditional Pacing SystemNCT01341522assess the pacing system-, MRI- and implant procedure-related complication-free rateRandomized · Open-label · Diagnostic | Phase 3 | Withdrawn | Procedure: MRI exam, control | Dual-chamber Pacemaker Placement | 0 | May 2013 | — | 2013-07-17 |
| Evaluation of the Performances of the Sleep Disordered Breathing Monitoring Function in PacemakerNCT01537718Event-based sensitivity of breathing troublesOpen-label · Diagnostic | Phase 3 | Completed | Device: REPLY 200 | Bradycardia | 40 | Nov 2012actual | — | 2013-07-17 |
| Predictive Risk Stratification Through T Variability in ICD Patients Without Pacing IndicationsNCT00560768TAV score and number of tachyarrhythmic events.Non-randomized · Open-label · Prevention | Phase 4 | Completed | Device: Ovatio VR 6250 or DR6550 | Sudden Cardiac Death | 198 | Aug 2012actual | — | 2015-01-12 |
| Clinical Evaluation Of The PARADYM RF DeviceNCT01193634Demonstration of the Right ventricular (RV) autothreshold algorithm performancesNon-randomized · Open-label · Diagnostic | Phase 3 | Completed | Device: VR 9250 / DR 9550 / CRT 9750 | Heart Failure | 75 | Mar 2012actual | — | 2014-06-18 |
| Natural Evolution of AV Conduction Disorders in Patients Implanted With Cardiac PacemakersNCT00531037observationalHigh degree AV blocks | — | Completed | — | Patients Implanted With a Pacemaker | 1,440 | Dec 2011actual | — | 2017-11-14 |
| Optimal Anti-tachycardia Therapy in Implantable Cardioverter-defibrillator (ICD) Patients Without Pacing IndicationsNCT00729703The first part is the time to first occurrence of inappropriate ICD shock therapy. The second part is the composite endpoint of time to first occurrence of death (all causes)or Hospitalizations due to cardio-vascular event.Randomized · Single-masked · Treatment | Phase 4 | Completed | Device: Ovatio DR 6550, OVATIO DR 6550 | Tachycardia | 462 | Dec 2011actual | — | 2015-01-13 |
| Impact of Ventricular Pacing in Unselected ICD/CRT-D PatientsNCT01169896observationalVT/VF episodes according to ventricular pacing (> and <50%) | — | Completed | — | Ventricular Tachycardia, Ventricular Fibrillation | 616 | Dec 2011actual | — | 2015-12-03 |
| Clinical Status Monitoring in Implantable Cardiac Defibrillator (ICD) Patients by Physiological Diagnosis (PhD) FunctionNCT01170624The objective is to demonstrate that agreement correlation is superior to 67%Non-randomized · Open-label · Diagnostic | Phase 4 | Terminatedsponsor's stated reason: Field Safety Notice related to potential ventricular oversensing associated to the PhD feature on Paradym ICDs | Device: ICD | Heart Failure | 388 | Sep 2011actual | — | 2015-01-12 |
| Clinical Evaluation Of The SonR Atrial Lead In Paradym RF DeviceNCT01169272Evaluation of the SonR lead safetyNon-randomized · Open-label · Diagnostic | Phase 3 | Completed | Device: CRT-SonR 9770 | Heart Failure | 100 | Jun 2011actual | — | 2014-06-18 |
| Evaluation of the SafeR Mode in Patients With a Dual Chamber Pacemaker IndicationNCT00562107The outcome measure is the % of ventricular pacing and hospitalizations for specified cardiac reasons (symptomatic AF, cardioversions for AF and heart failure)Randomized · Single-masked · Treatment | Phase 4 | Completed | Device: Symphony DR 2550 and REPLY DR cardiac pacemakers, Symphony DR 2550 and REPLY DR cardiac pacemakers | Assess the Benefits From the AAISafeR/SafeR Algorithm of Symphony 2550 or REPLYTM DR in a Wide Range of Pacemaker Patients. | 650 | Mar 2011actual | — | 2014-09-29 |
| Echocardiography and Peak Endocardial Acceleration (PEA) Measurements in Cardiac Resynchronization Therapy (CRT)NCT01066078observationalThe timings of mitral (tMC) and aortic (tAC) valves closure by echocardiography and sonR | — | Completed | Other: Echocardiography and SonR recording | Congestive Heart Failure | 216 | Oct 2009actual | — | 2010-03-05 |
| Biventricular Tachycardias Outcome TrialNCT00729235Incidence of slow ventricular tachycardias (Slow VTs) in CRT-ICD pts;Randomized · Single-masked · Treatment | Phase 4 | Completed | Device: Ovatio CRT 6750, Ovatio CRT 6750 | Biventricular Tachycardias | 481 | Dec 2008actual | — | 2011-12-22 |
| Clinical Evaluation on Advanced ResynchronizationNCT00658203The primary endpoint will be evaluated at 1 year (M12), in term of improved, unchanged or worsened patient's conditions, with a composite analysis of NYHA class evolution, heart-failure-related hospitalisations and Quality of Life evaluation.Randomized · Single-masked · Treatment | Phase 4 | Completed | Device: New Living CHF, New Living CHF | Heart Failure, Cardiomyopathy | 310 | Feb 2008actual | — | 2008-04-14 |
| Ventricular Arrhythmias Incidence According to Sleep Apnea Syndrome in Implantable Cardioverter-Defibrillator (ICD) PatientsNCT00708786The primary objective of this study is to assess the correlation between ventricular arrhythmias and Sleep apnoea syndrome in ICD patients during a 12-month follow-up.Non-randomized · Open-label · Treatment | Phase 4 | Completed | Device: ICD, CRT-D | Sleep Apnoea | 755 | Oct 2007actual | — | 2008-07-02 |
| Spontaneous Atrio Ventricular Conduction PreservationNCT00655213mean percentage of ventricular pacing between the randomized branches on a two-months period (M3 visit)Randomized · Double-masked · Treatment | Phase 4 | Completed | Device: Symphony D 2450, Symphony DR 2550 | Sinus Node Dysfunction, Bradycardia-Tachycardia Syndrome, Paroxysmal Atrioventricular Block | 622 | Dec 2006actual | — | 2008-04-09 |
| Prevention of Atrial Arrhythmia in Patients Without Atrioventricular (AV) Conduction DiseaseNCT01170611Atrial arrhythmia burdenRandomized · Open-label · Prevention | Phase 4 | Completed | Device: PACEMAKER SYMPHONY 2550 | Sinus Node Dysfunction, Brady Tachy Syndrome | 400 | — | — | 2010-07-27 |
| Clinical Evaluation Of The Nano Lv Lead System In Chronic Situation (LENEA)NCT01731210Freedom from left ventricular lead related complications through 1 monthOpen-label · Treatment | Phase 2/3 | Terminatedsponsor's stated reason: Study stopped due to investigational device deficiency | Device: implantation of the new LV lead: NANO system. | LV Lead, LV Therapy, LV Treatment, LV Microcable | 9 | — | — | 2018-03-13 |
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