Bundle Branch Pacing to Preserve Ejection Fraction in Atrial Fibrillation Trial

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorPoitiers University Hospital

About this trial

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

Eligibility criteria

Qualifiers

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).

Disqualifiers

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

Trial design

Treatments tested in this trial

  • LBBA pacing
  • Conventional pacing

Treatment groups

642 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Poitiers University Hospital

Lead sponsor

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