Bachmann Bundle Pacing for Prevention of New-Onset Atrial Fibrillation in Patients With Heart Failure
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorFu Wai Hospital, Beijing, China
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
Bachmann Bundle Pacing
Procedure/SurgeryA 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
Procedure/SurgeryThe 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.
Treatment groups
140 Participants
are divided into 2 treatment groupsGroup A: Bachmann Bundle PacingExperimental treatment 1 intervention
Group B: Traditional Right Atrial Appendage PacingActive comparator 1 intervention
Trial outcomes
Primary outcomes
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).
Time frame
12 months after device implantation2
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.
Time frame
Up to 12 months after device implantationSecondary outcomes
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.
Time frame
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.
Time frame
Baseline and 12 months after device implantation3
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.
Time frame
Baseline and 12 months after device implantation4
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.
Time frame
Baseline and 12 months after device implantationSponsors and contacts
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Source ClinicalTrials.gov
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