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

NCT07547449 | Not Yet Recruiting DMC

• 1 other identifier: 2025-2951
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Heart Failure; Atrial Fibrillation (AF); Cardiac Insufficiency

Keywords

Bachmann Bundle Pacing; Right Atrial Appendage Pacing; Cardiac Resynchronization Therapy; Implantable Cardioverter Defibrillator; Physiological Pacing; New-Onset Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

• Incidence of New-Onset Atrial Fibrillation

  The proportion of patients who develop new-onset atrial fibrillation (AF) confirmed by 12-lead ECG or 24-hour Holter monitoring within 12 months after cardiac pacing device implantation. New-onset AF is defined as the first documentation of AF with a duration ≥30 seconds in patients with no prior history of AF or paroxysmal AF (documented ≥3 months before enrollment).

  12 months after device implantation

• Time to Onset of New-Onset Atrial Fibrillation Post-Device Implantation

  Time from CRT/LBBP or ICD implantation to the first documentation of new-onset atrial fibrillation (AF) confirmed by 12-lead ECG or 24-hour Holter monitoring, with AF defined as an episode lasting ≥30 seconds. Time is recorded in days and analyzed using Kaplan-Meier survival methods.

  Up to 12 months after device implantation

Secondary Outcomes (17)

• Immediate Success Rate of Bachmann Bundle Pacing and Perioperative Complication Rate

  Intraoperatively (success rate) and 30 days post-implantation (perioperative complications)

• Absolute and percentage change in left atrial diameter/volume index from baseline to 12 months

  Baseline and 12 months after device implantation

• Change in mitral/tricuspid regurgitation grade from baseline to 12 months

  Baseline and 12 months after device implantation

• Absolute change in left ventricular end-diastolic diameter (LVEDD) from baseline to 12 months

  Baseline and 12 months after device implantation

• Absolute change in left ventricular end-systolic volume (LVESV) from baseline to 12 months

  Baseline and 12 months after device implantation

Study Arms (2)

Bachmann Bundle Pacing

EXPERIMENTAL

Patients receive atrial lead implantation at the Bachmann bundle region, identified by anatomical localization and intracardiac electrogram. Successful BBP is defined by characteristic ECG changes (positive P wave in I/II/III/aVF, biphasic/negative P wave in V1, narrowed P wave duration) and recording of Bachmann bundle potential. If BBP fails, patients are converted to RAA pacing, with failure reasons documented.

Procedure: Bachmann Bundle Pacing

Traditional Right Atrial Appendage Pacing

ACTIVE COMPARATOR

Patients receive conventional atrial lead implantation in the right atrial appendage (RAA), the standard clinical atrial pacing method. Intraoperative pacing parameters (threshold, sensing, impedance) are monitored identically to the experimental group to ensure normal pacing function. All patients continue guideline-directed medical therapy for heart failure throughout the study.

Procedure: Right Atrial Appendage Pacing

Interventions

Bachmann Bundle Pacing PROCEDURE

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.

Also known as: BBP

Bachmann Bundle Pacing

Right Atrial Appendage Pacing PROCEDURE

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.

Also known as: RAA Pacing

Traditional Right Atrial Appendage Pacing

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Fu Wai Hospital, Beijing, China: lead

Study Sites (1)

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

Beijing, Beijing Municipality, 100037, China

Location

Related Publications (4)

• Subramanian M, Yalagudri S, Saggu D, Singh J, Bootla D, Krishnamoorthy P, Chennapragda S, Narasimhan C. Electrogram-guided Bachmann bundle area pacing to correct interatrial block: Initial experience, safety, and feasibility. Heart Rhythm. 2025 Apr;22(4):1064-1070. doi: 10.1016/j.hrthm.2024.08.024. Epub 2024 Aug 20.

  PMID: 39168297 BACKGROUND

• Lustgarten DL, Habel N, Sanchez-Quintana D, Winget J, Correa de Sa D, Lobel R, Thompson N, Infeld M, Meyer M. Bachmann bundle pacing. Heart Rhythm. 2024 Sep;21(9):1711-1717. doi: 10.1016/j.hrthm.2024.03.1786. Epub 2024 Mar 27. No abstract available.

  PMID: 38552731 BACKGROUND

• Infeld M, Nicoli CD, Meagher S, Tompkins BJ, Wayne S, Irvine B, Betageri O, Habel N, Till S, Lobel J, Meyer M, Lustgarten DL. Clinical impact of Bachmann's bundle pacing defined by electrocardiographic criteria on atrial arrhythmia outcomes. Europace. 2022 Oct 13;24(9):1460-1468. doi: 10.1093/europace/euac029.

  PMID: 35304608 BACKGROUND

• Bailin SJ, Adler S, Giudici M. Prevention of chronic atrial fibrillation by pacing in the region of Bachmann's bundle: results of a multicenter randomized trial. J Cardiovasc Electrophysiol. 2001 Aug;12(8):912-7. doi: 10.1046/j.1540-8167.2001.00912.x.

  PMID: 11513442 BACKGROUND

MeSH Terms

Conditions

Heart Failure; Atrial Fibrillation

Interventions

4-boronic acid benzophenone

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Xiaohan Fan, MD, PhD

CONTACT

+8615611980322; fanxiaohan@fuwaihospital.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This trial uses a single-blind design masking outcomes assessors, plus statistical analysts, echocardiographers, and adverse event adjudicators (not listed in standard options). These personnel receive de-identified data without group assignment (Bachmann bundle pacing vs. RAA pacing) for outcome evaluation, echocardiography interpretation, and adverse event adjudication. Participants, care providers, and investigators are not masked due to the procedural nature of the pacing intervention-they must know the assigned group for implantation, pacemaker adjustment, and study oversight. No other parties are masked.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: March 25, 2026
• First Posted: April 23, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: April 23, 2026

Record last verified: 2026-03

Locations

CN (1)