Clinical Trial

Safety, Performance, and Clinical Benefit of Pacing the Left Bundle Branch Area - Post-Market Clinical Follow-up

Study acronym: SEPTA PMCF
Recruiting
View on ClinicalTrials.gov →
Summary
The goal of this observational post-market clinical Follow-up study is to learn about the long-term safety, performance, and clinical benefits of pacing the left bundle branch area (LBBAP) using the INGEVITY+ pacemaker lead in patients with bradycardia who need a pacemaker.
Protocol Amendment History 13 amendments
This ClinicalTrials.gov record has been amended 13 times since 2025-09-29; most recent amendment 2026-07-16.
Status change: Not Yet Recruiting → Recruiting 2025-12-16
Trial Details
NCT Number NCT07209852
Lead Sponsor Boston Scientific Corporation
Conditions Bradycardia, Atrioventricular Block, Sinus Node Dysfunction, Bundle-Branch Block
Enrollment 140 participants
Start Date 2025-12-19
Primary Completion 2029-08-31 (estimated)
Study Completion 2029-08-31 (estimated)
Updated on ClinicalTrials.gov 2026-08-12