Status:
RECRUITING
Atrial Fibrillation (AF) Ablation to Prevent Disease Progression of AF-induced Atrial Cardiomyopathy in Women and Men
Lead Sponsor:
University Medical Center Groningen
Conditions:
Fibrillation, Atrial
Atrial Cardiomyopathy
Eligibility:
All Genders
65-80 years
Phase:
NA
Brief 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 v...
Detailed Description
The RACE X trial investigates the impact of atrial cardiomyopathy (ACMP) and ablation timing on adverse outcomes in atrial fibrillation (AF) patients. ACMP leads to an atrial substrate less responsive...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
July 25 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 25 2029
Estimated Enrollment :
604 Patients enrolled
Trial Details
Trial ID
NCT06200311
Start Date
July 25 2024
End Date
July 25 2029
Last Update
October 18 2024
Active Locations (1)
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1
UMCG
Groningen, Netherlands, 9715BS