Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT07547449
NA

Bachmann Bundle Pacing for Prevention of New-Onset Atrial Fibrillation in Patients With Heart Failure

Sponsor: Fu Wai Hospital, Beijing, China

View on ClinicalTrials.gov

Summary

This is a multi-center, prospective, single-blind, randomized controlled clinical trial to evaluate the efficacy and safety of Bachmann bundle pacing (BBP) in preventing new-onset atrial fibrillation (AF) in patients with chronic cardiac insufficiency who have indications for cardiac resynchronization therapy with left bundle branch pacing (CRT/LBBP) or implantable cardioverter defibrillator (ICD) implantation. A total of 110 eligible patients will be randomly assigned 1:1 to the BBP group or the traditional right atrial appendage (RAA) pacing group. All patients will receive guideline-directed medical therapy (GDMT) for at least 3 months and standardized follow-up for 12 months after device implantation. The primary endpoint is the incidence of new-onset AF within 12 months after implantation. Secondary endpoints include time to first new-onset AF, procedural success rate, changes in cardiac function parameters, and incidence of adverse events. This study aims to provide high-level evidence-based medical evidence for BBP as a new atrial pacing strategy to prevent AF in heart failure patients.

Official title: Clinical Efficacy of Bachmann Bundle Pacing on New-Onset Atrial Fibrillation in Patients With Cardiac Insufficiency

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

140

Start Date

2026-04

Completion Date

2028-04

Last Updated

2026-04-23

Healthy Volunteers

No

Interventions

PROCEDURE

Bachmann Bundle Pacing

A minimally invasive endocardial pacing procedure where an atrial lead is placed at the Bachmann bundle region (located at the junction of the right atrium and left atrial appendage) under fluoroscopic and intracardiac electrogram guidance. Successful implantation is confirmed by characteristic ECG changes (positive P wave in leads I/II/III/aVF, biphasic/negative P wave in V1, P wave duration reduction \>10 ms in patients with interatrial block) and recording of the Bachmann bundle potential.

PROCEDURE

Right Atrial Appendage Pacing

The standard clinical atrial pacing procedure where an atrial lead is implanted in the right atrial appendage via transvenous access, guided by fluoroscopy. Pacing parameters (threshold, sensing, impedance) are optimized intraoperatively to ensure stable atrial capture, consistent with current clinical practice guidelines for cardiac pacing in heart failure patients.

Locations (1)

Fuwai Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China