NCT07547449Not yet recruiting
Bachmann Bundle Pacing for Prevention of New-Onset Atrial Fibrillation in Patients With Heart Failure
Clinical Efficacy of Bachmann Bundle Pacing on New-Onset Atrial Fibrillation in Patients With Cardiac Insufficiency
Source: ClinicalTrials.gov · Last updated 23 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 140 (estimated)
- First submitted
- 25 Mar 2026
- Start date
- 1 Apr 2026
- Primary completion date
- 30 Apr 2028
- Lead sponsor
- Fu Wai Hospital, Beijing, China
- Diseases
- Heart failure, Atrial fibrillation
- NCT number
- NCT07547449
What you commit to
- Study type: Interventional
- Planned participants: 140
- From 1 Apr 2026 to the primary completion date, 30 Apr 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous history of atrial fibrillation;
- Previous cardiac surgery, or requiring surgical treatment for severe structural heart disease within 1 year;
Other illness
- Status after mechanical tricuspid valve replacement, or congenital heart disease (including dextrocardia, transposition of great arteries, single left persistent superior vena cava);
- Pregnancy, planned pregnancy, or heart transplantation;
Other
- Expected survival time less than 12 months;
- Patient refusal to participate in the study.
Who the study is looking for
- 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.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fuwai Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.