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

Not yet recruitingOBSERVATIONAL
Enrollment

140

Participants

Timeline

Start Date

January 15, 2026

Primary Completion Date

August 31, 2029

Study Completion Date

August 31, 2029

Conditions
BradycardiaAtrioventricular BlockSinus Node DysfunctionBundle-Branch Block
Interventions
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.

Sponsors
All Listed Sponsors
lead

Boston Scientific Corporation

INDUSTRY

NCT07209852 - Safety, Performance, and Clinical Benefit of Pacing the Left Bundle Branch Area - Post-Market Clinical Follow-up | Biotech Hunter | Biotech Hunter