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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65-80
SponsorUniversity Medical Center Groningen

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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))

Trial design

Treatments tested in this trial

  • Pulmonary vein isolation
  • Pharmacological rhythm management

Treatment groups

604 Participants
are divided into 2 treatment groups