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Bundle Branch Pacing to Preserve Ejection Fraction in Atrial Fibrillation Trial

Not Yet RecruitingNA

Sponsor: Poitiers University Hospital

Conditions: Permanent Atrial Fibrillation, Preserved Ejection Fraction

Interventions: LBBA pacing, Conventional pacing

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 overview

Sex: ALL

Age: 18 Years to 90 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Age ≥ 18 years and \<90 years
* Atrial fibrillation requiring ventricular pacing because of

  1. rapid atrial fibrillation requiring atrioventricular node ablation; or
  2. 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.

Exclusion Criteria:

* 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