Atrial Fibrillation (AF) Ablation to Prevent Disease Progression of AF-induced Atrial Cardiomyopathy in Women and Men
Recruiting · NCT06200311 · Interventional (participants receive a specific treatment) · Lead sponsor: University Medical Center Groningen
View the official record on ClinicalTrials.gov →Interventions studied
Pharmacological rhythm managementPulmonary vein isolation
What this trial is about
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 can take part
Age range
65 Years to 80 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed.
- UMCG - Groningen, Netherlands