RECRUITINGINTERVENTIONAL
Atrial Fibrillation (AF) Ablation to Prevent Disease Progression of AF-induced Atrial Cardiomyopathy in Women and Men
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.
Who May Be Eligible (Plain English)
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 willing to sign a consent form 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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
PROCEDURE
Pulmonary vein isolation
Pulmonary vein isolation using pulsed field ablation (PFA), cryoballoon or radiofrequency ablation (RFA)
DRUG
Pharmacological rhythm management
1st line: rate control, 2nd line: pharmacological rhythm management. 3rd line: AF ablation
Locations (1)
UMCG
Groningen, Netherlands