Bundle Branch Pacing to Preserve Ejection Fraction in Atrial Fibrillation Trial

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

Interventions

PROCEDURE

LBBA pacing

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

Conventional pacing

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.

Sponsors & Collaborators

• University Hospital, Grenoble

  collaborator OTHER

• Nouvelles Cliniques Nantaises, Nantes

  collaborator UNKNOWN

• Centre Hospitalier Universitaire de Besancon

  collaborator OTHER

• Centre Hospitalier de PAU

  collaborator OTHER

• Centre Cardiologique du Nord, St Denis

  collaborator UNKNOWN

• Centre Hospitalier Universitaire de Saint Etienne

  collaborator OTHER

• LA ROCHE SUR YON HOSPITAL

  collaborator UNKNOWN

• Centre Hospitalier Régional d'Orléans

  collaborator OTHER

• University Hospital, Tours

  collaborator OTHER

• Poitiers University Hospital

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-09-15

Primary Completion

2028-08-14

Completion

2030-08-14