Clinical Research Directory
Browse clinical research sites, groups, and studies.
Bachmann Bundle Pacing for Prevention of New-Onset Atrial Fibrillation in Patients With Heart Failure
Sponsor: Fu Wai Hospital, Beijing, China
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
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.
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