Bundle Branch Pacing to Preserve Ejection Fraction in Atrial Fibrillation Trial

NCT07759700 | Not Yet Recruiting

• 1 other identifier: BEAT STUDY
• Study Type: interventional
• Target: 642
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical trial is to learn whether left bundle branch area pacing, a technique designed to activate the heart's natural electrical conduction system, is better than conventional right ventricular pacing in adults with permanent atrial fibrillation, preserved heart pumping function, and a need for a pacemaker. The main questions it aims to answer are: Does left bundle branch area pacing reduce the risk of death, unplanned hospitalization for heart failure, or the need to replace the initial pacing system with biventricular pacing over 2 years? Does it better preserve heart function and quality of life, without increasing pacemaker-related complications? Researchers will compare left bundle branch area pacing with conventional right ventricular pacing. A total of 642 participants will be randomly assigned to receive one of these two pacing strategies. Participants will: Have a single-chamber pacemaker implanted using either left bundle branch area pacing or conventional right ventricular pacing Undergo electrocardiograms, echocardiograms, and pacemaker checks during 2 years of follow-up Attend follow-up visits approximately 2, 12, and 24 months after implantation Be contacted by telephone approximately 6 and 18 months after implantation Complete questionnaires about their health and quality of life at the beginning and end of the study

Conditions

Permanent Atrial Fibrillation; Preserved Ejection Fraction

Keywords

atrial fibrillation; preserved ejection fraction; heart failure; pacemaker; left-bundle-branch-area pacing

Outcome Measures

Primary Outcomes (1)

• Proportion of post-implantation adverse events

  proportion of post-implantation adverse events, combining all-cause mortality, unplanned hospitalization related to heart failure, and upgrade to biventricular pacing.

  At two years

Secondary Outcomes (10)

• Left ventricular ejection fraction

  At 2 years post-implantation.

• Left ventricular end-systolic volume

  At 2 years post-implantation

• Time to composite outcome

  Through study completion, an average of 2 years

• Unplanned hospitalization related to heart failure

  During the 2-year follow-up perio

• All-cause mortality

  During the 2-year follow-up period

Study Arms (2)

LBBA pacing

EXPERIMENTAL

The LBBA pacing group will be composed of patients randomized to receive a single chamber pacemaker with a ventricular lead implanted in the LBBA of the cardiac conduction system through the interventricular septum.

Procedure: LBBA pacing

Conventional pacing

ACTIVE COMPARATOR

The conventional pacing group will be composed of patients randomized to receive a single chamber pacemaker with a ventricular lead implanted either at the apex or the septum of the right ventricle.

Procedure: Conventional pacing

Interventions

LBBA pacing PROCEDURE

The LBBA pacing group will be composed of patients randomized to receive a single chamber pacemaker with a ventricular lead implanted in the LBBA of the cardiac conduction system through the interventricular septum.

LBBA pacing

Conventional pacing PROCEDURE

The conventional pacing group will be composed of patients randomized to receive a single chamber pacemaker with a ventricular lead implanted either at the apex or the septum of the right ventricle.

Conventional pacing

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years and \<90 years
• Atrial fibrillation requiring ventricular pacing because of
• rapid atrial fibrillation requiring atrioventricular node ablation; or
• slow atrial fibrillation i.e. ≤ 50 bpm on admission ECG).
• Left ventricular ejection fraction ≥50%.
• Affiliated person or beneficiary of the French social security scheme
• Having given their informed consent.

You may not qualify if:

• Indication for an implantable cardioverter defibrillator.
• Presence of a mechanical tricuspid valve
• Any prior attempt at implantation of an implantable cardioverter defibrillator, cardiac resynchronization therapy or LBBA pacing
• Glomerular filtration rate \<40 mL/min/1,73m2 with CKD-EPI formula
• Chronic respiratory failure
• Serious medical condition with life expectancy of \<2 years
• Pregnant or breastfeeding women, women of childbearing age who do not have effective contraception (hormonal/mechanical: per os, injectable, transcutaneous, implantable, intrauterine device, or surgical: tubal ligation, hysterectomy, total oophorectomy)
• Persons benefiting from enhanced protection, i.e. minors, persons deprived of their liberty by a judicial or administrative decision, persons staying in a health or social institution, adults under legal protection, and finally patients in emergency situations

Sponsors & Collaborators

• Poitiers University Hospital: lead
• University Hospital, Grenoble: collaborator
• Nouvelles Cliniques Nantaises, Nantes: collaborator
• Centre Hospitalier Universitaire de Besancon: collaborator
• Centre Hospitalier de PAU: collaborator
• Centre Cardiologique du Nord, St Denis: collaborator
• Centre Hospitalier Universitaire de Saint Etienne: collaborator
• LA ROCHE SUR YON HOSPITAL: collaborator
• Centre Hospitalier Régional d'Orléans: collaborator
• University Hospital, Tours: collaborator

MeSH Terms

Conditions

Atrial Fibrillation; Heart Failure

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Rodrigue GARCIA, MD, PhD

CONTACT

+33516604089; sec.rythmologie@chu-poitiers.fr

Céline DELETAGE, MSc

CONTACT

celine.deletage@chu-poitiers.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2026
• First Posted: August 12, 2026
• Study Start (Estimated): September 15, 2026
• Primary Completion (Estimated): August 14, 2028
• Study Completion (Estimated): August 14, 2030
• Last Updated: August 12, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share