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

RECRUITINGN/ASponsored by University Medical Center Groningen
Actively Recruiting
PhaseN/A
SponsorUniversity Medical Center Groningen
Started2024-07-25
Est. completion2029-07-25
Eligibility
Age65 Years – 80 Years
Healthy vol.Accepted

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

Age: 65 Years – 80 YearsHealthy volunteers accepted
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

Conditions3

Atrial CardiomyopathyFibrillation, AtrialHeart Disease

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