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Left Bundle Branch Area Pacing or Biventricular Pacing in AF and Left Ventricular Dysfunction

RecruitingNAAges 18 Years - anyAllsrdpiers
NCT06620705 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

It is unknown whether left bundle branch area pacing (LBBAP) or biventricular pacing best prevents or reverses left ventricular (LV) adverse remodelling in patients with atrial fibrillation (AF) who require ventricular pacing or CRT. This randomized non-inferiority cross-over trial will compare left ventricular end-systolic volume change and secondary endpoints between LBBAP and biventricular pacing in patients with AF and LV dysfunction.

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📋 Eligibility rules (as published)
INCLUSION CRITERIA In order to be eligible to participate in this study, a subject must meet all of the following criteria: * Adults ≥18 years with permanent AF and LVEF \< 50% who either require ventricular pacing because of bradycardia including patients undergoing AV junction ablation, or have an indication for cardiac resynchronization therapy. * Expected percentage of ventricular pacing \> 40% * ≥ 3 months of heart failure medication optimization Of note, patients who already have a device, but require an upgrade to a CRT device, can also be included EXCLUSION CRITERIA A potential subject who meets any of the following criteria will be excluded from participation in this study: * Age \< 18 years * Pregnancy or active pregnancy wish * Not eligible for implantation of an RV lead, LBBAP lead, or LV lead in the coronary sinus * Recent valve intervention/surgery or acute myocardial infarction (\< 6 months) * NYHA functional class IV heart failure, left ventricular assist device or cardiac transplant
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What it tests

  • Left bundle branch area pacing
  • Biventricular pacing
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Where

2 sites
Aarhus University Hospital
Aarhus N, Denmark
Leiden University Medical Center
Leiden, Netherlands
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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