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

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Conditions studied: Heart Failure, Atrial Fibrillation (AF), Cardiac Insufficiency

In brief

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.

Key facts

Study ID

NCT07547449

Run by

Fu Wai Hospital, Beijing, China

People needed

140

Starts

2026-04-01

Expected to finish

2028-04-01

Last updated by the study team

2026-04-23

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Aged between 18 and 70 years old;
• Diagnosis of chronic cardiac insufficiency according to current guidelines, and received guideline-directed medical therapy (GDMT) for at least 3 months;
• Have indications for CRT/LBBP or ICD implantation, and expected atrial pacing ratio > 20%, including: Sinus rhythm, QRS duration > 120ms, LBBB, LVEF ≤ 35% with symptomatic heart failure; Sinus rhythm, QRS duration ≥ 150ms, non-LBBB, LVEF ≤ 35% with symptomatic heart failure; Sinus rhythm, QRS duration > 120ms, LBBB, LVEF 36%-50% with symptomatic heart failure; Symptomatic heart failure with LVEF ≤ 50% and expected ventricular pacing ratio > 20%; Symptomatic heart failure with LVEF ≤ 50% requiring ICD implantation for primary or secondary sudden death prevention, with atrial pacing indication due to sinus bradycardia or expected atrial pacing ratio > 20%;
• Patients with pacing-induced cardiomyopathy requiring upgrade therapy, in sinus rhythm, and requiring reimplantation of atrial lead;
• Signed written informed consent form approved by the ethics committee.

You may not qualify if…

• Expected survival time less than 12 months;
• Status after mechanical tricuspid valve replacement, or congenital heart disease (including dextrocardia, transposition of great arteries, single left persistent superior vena cava);
• Previous history of atrial fibrillation;
• Previous cardiac surgery, or requiring surgical treatment for severe structural heart disease within 1 year;
• Pregnancy, planned pregnancy, or heart transplantation;
• Patient refusal to participate in the study.

Where it is running

• Fuwai Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences — Beijing, Beijing Municipality, China

Full record on ClinicalTrials.gov

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