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Bachmann Bundle Pacing for Prevention of New-Onset Atrial Fibrillation in Heart Failure NCT07547449

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Summary

A multi-center, prospective, single-blind, randomized controlled clinical trial registered on ClinicalTrials.gov (NCT07547449) evaluating Bachmann bundle pacing (BBP) versus traditional right atrial appendage (RAA) pacing in 110 patients with chronic cardiac insufficiency requiring cardiac resynchronization therapy or implantable cardioverter defibrillator implantation. All patients receive guideline-directed medical therapy for at least 3 months with 12-month standardized follow-up after device implantation. Primary endpoint is incidence of new-onset atrial fibrillation within 12 months. Study is listed as having primary completion anticipated on April 23, 2026.

“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.”

NIH , verbatim from source
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About this source

ClinicalTrials.gov is the NIH-run registry of every clinical trial conducted in the United States, plus most international trials sponsored by US-based companies or institutions. By federal law, sponsors must register Phase 2 through Phase 4 studies before enrolling patients and post results within a year of completion. This feed tracks every new trial registration and study update, around 700 a month: drug interventions, device studies, behavioral protocols, observational research. Watch this if you scout drug candidates moving into mid or late-stage development, monitor competitor pipelines, or follow rare disease research where new trials signal patient hope. GovPing parses sponsor, phase, intervention, and target indication on each entry.

What changed

A new clinical trial registration entry for NCT07547449 has been added to ClinicalTrials.gov, documenting a randomized controlled trial evaluating Bachmann bundle pacing (BBP) as a strategy to prevent new-onset atrial fibrillation in patients with chronic cardiac insufficiency who have indications for cardiac resynchronization therapy or implantable cardioverter defibrillator implantation. The trial plans to enroll 110 patients randomized 1:1 to BBP or traditional right atrial appendage pacing, with guideline-directed medical therapy for at least 3 months and 12-month post-implantation follow-up. The primary completion date is listed as April 23, 2026.

Affected parties include cardiac rhythm management device manufacturers, hospitals and health systems conducting cardiac device implantation research, and clinical investigators specializing in cardiac electrophysiology. The trial aims to provide evidence-based medical data supporting BBP as a new atrial pacing strategy for AF prevention in heart failure patients.

Archived snapshot

Apr 23, 2026

GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.

← ClinicalTrials.gov Studies

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

N/A NCT07547449 Kind: NA Apr 23, 2026

Abstract

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

Interventions: Bachmann Bundle Pacing, Right Atrial Appendage Pacing

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Last updated

Classification

Agency
NIH
Instrument
Notice
Branch
Executive
Legal weight
Non-binding
Stage
Final
Change scope
Minor

Who this affects

Applies to
Healthcare providers Clinical investigators Medical device makers
Industry sector
3345 Medical Device Manufacturing 6221 Hospitals & Health Systems
Activity scope
Clinical trial conduct Medical device implantation Cardiac treatment research
Geographic scope
United States US

Taxonomy

Primary area
Healthcare
Operational domain
Clinical Operations
Topics
Medical Devices Pharmaceuticals

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