RecruitingNot ApplicableNCT06200311

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

Sponsor

University Medical Center Groningen

Enrollment

604 participants

Start Date

Jul 25, 2024

Study Type

INTERVENTIONAL

Conditions

Fibrillation, Atrial Atrial Cardiomyopathy

Summary

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

Min Age: 65 YearsMax Age: 80 Years

Inclusion Criteria4

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 Criteria12

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