Effectiveness of the EMPOWER™ Modular Pacing System and EMBLEM™ Subcutaneous ICD to Communicate Antitachycardia Pacing
← catalyst calendarSponsored by Boston Scientific Corporation (industry) · BSX — their whole pipeline →.
Phase
Not applicable
Status
Active, not recruiting
Study type
Interventional
Design
Na · None · Treatment
Enrollment
297actual
Sites
38
Countries
Austria, Canada, Czechia +6
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2021-07-20 | actual | When the study began enrolling |
| Primary completion | 2024-05-06 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2030-12-31 | estimated | The whole study's end, after follow-up |
| First posted | 2021-03-15 | actual | When this record first appeared on the registry |
| Results posted | 2025-06-26 | actual | When the sponsor posted results to the registry |
| Record updated | 2026-07-23 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Tachycardia, Ventricular
- Arrhythmia, Ventricular
Intervention
- Device: mCRM Therapy System — also filed as Communication of S-ICD to Leadless Cardiac Pacemaker (LCP)
Primary outcomes
what the primary-completion date above is the date OFSafety Endpoint 1: Percentage of Subjects Without Major EMPOWER MPS System- or Procedure-Related Complications Through 6 Months
measured Implant through 6 Months Post-Implant
Safety Endpoint 2: Percentage of Subjects Without Major EMPOWER MPS System- or Procedure-Related Complications Through 12 Months
measured Implant through 12 Months Post-Implant
Primary Effectiveness Endpoint 1: Percentage of Body Postures With Communication Success Between the S-ICD and EMPOWER PG
measured At the 6 Month Follow-up
Primary Effectiveness Endpoint 2: Percentage of Subjects Classified as a Pacing Capture Threshold (PCT) Responder
measured At the 6 Month Follow-up
Posted documents
hosted by the registry — we link, never re-serveStudy Protocolposted 2022-04-29 · 1.7 MB · Prot_000.pdf
Statistical Analysis Planposted 2025-05-22 · 289 KB · SAP_002.pdf
Publications
- PMID 38767244 — reports results
- PMID 37520021 — cited as background
- PMID 41231774 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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