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โ† Trials
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Bundle Branch Pacing to Preserve Ejection Fraction in Atrial Fibrillation Trial

RecruitingNAAges 18 Years - 90 YearsAllPoitiers University Hospital
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Age โ‰ฅ 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. โ‰ค 50 bpm on admission ECG). * Left ventricular ejection fraction โ‰ฅ50%. * 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
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What it tests

  • LBBA pacing
  • Conventional pacing
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Where

1 site
CHU Poitiers
Poitiers, France
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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