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Heart FailureNCT07547449

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

A study testing Bachmann Bundle Pacing and Right Atrial Appendage Pacing in people with Heart Failure and Atrial Fibrillation (AF), run by Fu Wai Hospital, Beijing, China at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Bachmann Bundle Pacing and Right Atrial Appendage Pacing
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
140 participants
Where
1 siteChina
Study dates
Apr 2026to Apr 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Xiaohan Fan, MD, PhD contact

+8615611980322

fanxiaohan@fuwaihospital.org

China1 site

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

    Beijing, Beijing Municipality, 100037

Other trials in China

About this study

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

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.

Read the detailed description

Background Chronic heart failure (HF) is a prevalent and prognostically poor cardiovascular disorder, with atrial fibrillation (AF) being the most common arrhythmia comorbid with HF. The bidirectional interaction between HF and AF forms a vicious cycle, significantly elevating the risks of mortality, hospitalization, and stroke in affected patients. Epidemiological data indicate that the cumulative incidence of AF following pacemaker implantation reaches 30-40%, a rate markedly higher than that in the general population without pacemaker implantation.

Traditional right atrial appendage (RAA) pacing, the most widely used clinical atrial pacing approach, induces prolonged interatrial conduction, asynchronous atrial contraction, and hemodynamic perturbations, which predispose patients to AF. The Bachmann bundle represents the most physiological atrial pacing site; pacing in this region achieves synchronous activation of the left and right atria, producing a narrower P wave compared with sinus rhythm and traditional RAA pacing. While prior studies have suggested that Bachmann bundle pacing (BBP) may reduce the recurrence and progression of atrial arrhythmias, there remains a paucity of prospective randomized controlled trials investigating the efficacy of BBP in preventing new-onset AF in HF patients undergoing cardiac resynchronization therapy with left bundle branch pacing (CRT/LBBP) or implantable cardioverter defibrillator (ICD) implantation.

Study Objectives The primary objective of this study is to determine whether BBP reduces the incidence of new-onset AF within 12 months of device implantation, compared with traditional RAA pacing, in HF patients with indications for CRT/LBBP or ICD implantation. Secondary objectives include evaluating the impact of BBP on the time to first new-onset AF, procedural safety, cardiac function parameters, electrophysiological indices, and clinical adverse events (including HF rehospitalization, all-cause death, and stroke) during the 12-month follow-up period.

Study Procedures

  1. Screening and Baseline Assessment Eligible patients are identified per predefined inclusion and exclusion criteria. Following written informed consent, baseline data are collected, including demographic characteristics, medical history, 12-lead electrocardiogram (ECG), 24-hour Holter monitoring, transthoracic echocardiography, New York Heart Association (NYHA) functional classification, 6-minute walk test results, and N-terminal pro-brain natriuretic peptide (NT-proBNP) levels.
  2. Randomization Patients are stratified by implant device type (CRT/LBBP or ICD) and randomized in a 1:1 ratio to the BBP group or the RAA pacing group via a central randomization system.
  3. Intervention Patients in the BBP group undergo atrial lead implantation at the Bachmann bundle region, identified via anatomical localization and intracardiac electrogram recording. Successful BBP is defined by characteristic ECG changes: a positive P wave in leads I, II, III, and aVF; a biphasic or negative P wave in lead V1; a P wave duration narrowed by >10 ms compared with baseline (in patients with pre-existing interatrial block); and documentation of the Bachmann bundle potential. If BBP implantation fails, the patient is immediately converted to RAA pacing, with the cause of failure recorded in detail. Intraoperative pacing parameters (threshold, sensing, impedance) are monitored in both groups.
  4. Follow-up All patients undergo follow-up assessments at 1 week, 3 months, 6 months, 9 months, and 12 months post-implantation. Follow-up evaluations include ECG, 24-hour Holter monitoring, pacemaker programming, echocardiography, NYHA classification reassessment, 6-minute walk test, NT-proBNP measurement, medication adjustment tracking, and adverse event reporting.
  5. Statistical Analysis All data are analyzed in accordance with the intention-to-treat (ITT) principle. The primary endpoint is compared using analysis of covariance, and the time to first new-onset AF is evaluated via the Kaplan-Meier method with log-rank testing. Continuous variables are compared using the t-test or Wilcoxon rank-sum test, while categorical variables are analyzed with the chi-square test or Fisher's exact test. A two-sided P value < 0.05 is considered statistically significant.
Being tested
Bachmann Bundle Pacing, Right Atrial Appendage Pacing
Keywords
Bachmann Bundle Pacing, Right Atrial Appendage Pacing, Cardiac Resynchronization Therapy, Implantable Cardioverter Defibrillator, Physiological Pacing, New-Onset Atrial Fibrillation
Medical subject headings
Heart Failure, Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bachmann Bundle PacingProcedure or surgery

    Also called BBP

    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 PacingProcedure or surgery

    Also called RAA 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.

Study groups in NCT07547449
Study groupRoleWhat they receive
Bachmann Bundle PacingExperimentalPatients 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.
Receives: Procedure: Bachmann Bundle Pacing
Traditional Right Atrial Appendage PacingActive comparatorPatients 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.
Receives: Procedure: Right Atrial Appendage Pacing

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 12 months after device implantation

  2. 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.

    Measured: Up to 12 months after device implantation

Secondary outcomes (17)

  1. Immediate Success Rate of Bachmann Bundle Pacing and Perioperative Complication Rate

    Immediate success of Bachmann bundle pacing is defined as stable lead placement with successful atrial capture and characteristic ECG changes intraoperatively; perioperative complications (occurring within 30 days post-surgery) include lead dislodgement, pneumothorax, cardiac tamponade, and pocket hematoma, with incidence calculated as the proportion of patients with at least one complication in each group.

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

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

    Absolute and percentage changes in left atrial diameter (mm) and left atrial volume index (mL/m²) measured by transthoracic echocardiography at 12 months post-implantation compared with baseline.

    Measured: Baseline and 12 months after device implantation

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

    Change in mitral and tricuspid regurgitation grade (graded 0-IV) measured by transthoracic echocardiography at 12 months post-implantation compared with baseline.

    Measured: Baseline and 12 months after device implantation

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

    Absolute change in LVEDD (mm) measured by transthoracic echocardiography at 12 months post-implantation compared with baseline.

    Measured: Baseline and 12 months after device implantation

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

    Absolute change in LVESV (mL) measured by transthoracic echocardiography at 12 months post-implantation compared with baseline.

    Measured: Baseline and 12 months after device implantation

  6. Change in New York Heart Association (NYHA) functional class from baseline to 12 months

    Change in NYHA functional class (graded I-IV) at 12 months post-implantation compared with baseline.

    Measured: Baseline and 12 months after device implantation

  7. Absolute change in 6-minute walk test (6MWT) distance from baseline to 12 months

    Absolute change in 6MWT distance (meters) at 12 months post-implantation compared with baseline

    Measured: Baseline and 12 months after device implantation

  8. Absolute change in plasma NT-ProBNP level from baseline to 12 months

    Absolute change in plasma NT-ProBNP level (pg/mL) measured by chemiluminescent immunoassay at 12 months post-implantation compared with baseline.

    Measured: Baseline and 12 months after device implantation

  9. Comparison of P-wave duration from baseline to 12 months

    Comparison of P-wave duration (ms) in the supine position (mean of 3 consecutive readings) between baseline and 12 months post-implantation

    Measured: Baseline and 12 months after device implantation

  10. Comparison of P-wave amplitude from baseline to 12 months

    Comparison of P-wave amplitude (mV) in the supine position (mean of 3 consecutive readings) between baseline and 12 months post-implantation

    Measured: Baseline and 12 months after device implantation

  11. Comparison of P-wave vector from baseline to 12 months

    Comparison of P-wave vector in the supine position between baseline and 12 months post-implantation.

    Measured: Baseline and 12 months after device implantation

  12. Prevalence of interatrial block at baseline and 12 months

    Prevalence of interatrial block (diagnosed by ECG criteria) in the supine position between baseline and 12 months post-implantation

    Measured: Baseline and 12 months after device implantation

  13. Comparison of ventricular pacing threshold from baseline to 12 months

    Comparison of ventricular pacing threshold (V) in the supine position (mean of 3 consecutive readings) between baseline and 12 months post-implantation.

    Measured: Baseline and 12 months after device implantation

  14. Comparison of sensing threshold from baseline to 12 months

    Comparison of sensing threshold (mV) in the supine position (mean of 3 consecutive readings) between baseline and 12 months post-implantation

    Measured: Baseline and 12 months after device implantation

  15. Comparison of lead impedance from baseline to 12 months

    Comparison of lead impedance (Ω) in the supine position (mean of 3 consecutive readings) between baseline and 12 months post-implantation.

    Measured: Baseline and 12 months after device implantation

  16. Incidence of Procedure Complications Within 12 Months Post-Implantation

    Cumulative incidence of long-term surgical complications (including lead fracture, chronic pocket infection, lead dislodgement, and cardiac perforation) within 12 months post-implantation, with complications adjudicated by an independent committee using VARC-3 criteria for severity and causality.

    Measured: 12 months after device implantation

  17. Incidence of Heart Failure Rehospitalization, All-Cause Death, and Stroke Within 12 Months

    Cumulative incidence of heart failure rehospitalization (unplanned admission for worsening HF), all-cause mortality, and ischemic/hemorrhagic stroke within 12 months post-implantation. All events are documented via medical records and confirmed by the study team.

    Measured: 12 months after device implantation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Apr 2026
  2. Study startApr 2026 (estimated)
  3. Primary completionApr 2028 (estimated)
  4. Study completionApr 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
140 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07547449
Sponsor's protocol ID
2025-2951
Status last verified
Mar 2026
First submitted
25 Mar 2026
Last updated
23 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: The decision to share individual participant data (IPD) is currently undecided and will be reassessed upon completion of the study. Considerations will include compliance with Chinese regulations on medical data privacy, ethical approval requirements for data sharing, and the need to protect participants' confidential health information. A formal IPD sharing plan will be developed if deemed appropriate post-study, in accordance with international clinical research standards.

Publications

  • 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.

    PubMed 39168297

  • 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.

    PubMed 38552731

  • 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.

    PubMed 35304608

  • 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.

    PubMed 11513442

Questions about this trial

What is this clinical trial studying?

A study testing Bachmann Bundle Pacing and Right Atrial Appendage Pacing in people with Heart Failure and Atrial Fibrillation (AF), run by Fu Wai Hospital, Beijing, China at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Xiaohan Fan, MD, PhD (+8615611980322, fanxiaohan@fuwaihospital.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of New-Onset Atrial Fibrillation (time frame: 12 months after device implantation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07547449, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.

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