NCT07209852

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

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 140 (estimated)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bradycardia
• Atrioventricular Block
• Sinus Node Dysfunction
• Bundle-Branch Block

Interventions

Type	Name	Description
DEVICE	Pacemaker lead	The pacemaker lead under investigation is a bipolar, steroid-releasing pacemaker electrode with active fixation (IS-1 connection) designed for chronic stimulation and sensing in the right atrium, right ventricle or left bundle branch area (LBBA). In this study, the lead is implanted in the LBBA and connected to a single- or dual-chamber pacemaker. Implantation is performed using a compatible, CE-marked catheter for pacemaker implantation.

Timeline

• Start date: 2025-12-19
• Primary completion: 2029-08-31
• Completion: 2029-08-31
• First posted: 2025-10-07
• Last updated: 2026-04-03

Locations

13 sites across 7 countries: Belgium, France, Germany, Italy, Spain, Switzerland, United Kingdom

Regulatory

• FDA-regulated device study