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Atrial Fibrillation (AF) Ablation to Prevent Disease Progression of AF-induced Atrial Cardiomyopathy in Women and Men

RecruitingNAAges 65 Years - 80 YearsAllUniversity Medical Center Groningen
NCT06200311 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The goal of clinical trial is to compare AF ablation to pharmacological rhythm management (being rate or rhythm control) in AF patients with signs of atrial cardiomyopathy (as defined by left atrial volume index \>34 ml/m2) The main objective it aims to answer is to determine whether AF ablation compared to pharmacological rhythm management in ACMP patients with AF reduces the incidence of the composite primary endpoint of CV death and first CV hospitalization/urgent visit.

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📋 Eligibility rules (as published)
Inclusion criteria * Confirmed ACMP (LAVI \>34 ml/m2) * ECG-confirmed AF * Age: 65-80 years old * Patients eligible for both treatment strategies judged by the treating physician signed and dated informed consent prior to admission to the trial Exclusion criteria * Longstanding (\>1 year) persistent or permanent (accepted) AF * Previous left atrial (LA) ablation or LA surgery * AF due to a reversible cause (e.g. hyperthyroidism, post-operative AF) * Recent (\<90 days) acute coronary syndrome, stroke/TIA or cardiac intervention (Cardiac interventions include percutaneous coronary intervention, coronary artery bypass grafting, and heart valve repair or replacement (endovascular or surgical)) * Intracardiac thrombus * HF NYHA III/IV * Impaired renal function, defined as estimated glomerular filtration rate ≤25 ml/min/1.73m2 * Presence of (or scheduled for) mechanical assist device or heart transplant * Severe aortic or mitral valve disease * Complex congenital heart disease * Life expectancy \<1 year * Currently enrolled in another clinical randomized trial
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What it tests

  • Pulmonary vein isolation
  • Pharmacological rhythm management
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Where

1 site
UMCG
Groningen, 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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