Actively Recruiting
Atrial Fibrillation (AF) Ablation to Prevent Disease Progression of AF-induced Atrial Cardiomyopathy in Women and Men
Led by University Medical Center Groningen · Updated on 2024-10-18
604
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Official Title
Atrial Fibrillation (AF) Ablation to Prevent Disease Progression of AF-induced Atrial Cardiomyopathy in Women and Men
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed atrial cardiomyopathy with left atrial volume index greater than 34 ml/m2
- ECG-confirmed atrial fibrillation
- Age between 65 and 80 years
- Eligible for both AF ablation and pharmacological rhythm management as judged by the treating physician
- Signed and dated informed consent before joining the trial
You will not qualify if you...
- Longstanding persistent or permanent atrial fibrillation lasting longer than 1 year
- Previous left atrial ablation or left atrial surgery
- Atrial fibrillation caused by a reversible condition such as hyperthyroidism or post-operative AF
- Recent (within 90 days) acute coronary syndrome, stroke, transient ischemic attack, or cardiac intervention including coronary procedures or valve repair/replacement
- Presence of intracardiac thrombus
- Heart failure classified as NYHA class III or IV
- Kidney impairment with estimated glomerular filtration rate less than or equal to 25 ml/min/1.73m2
- Presence or planned use of mechanical heart assist device or heart transplant
- Severe aortic or mitral valve disease
- Complex congenital heart disease
- Life expectancy less than 1 year
- Currently participating in another randomized clinical trial
AI-Screening
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Trial Site Locations
Total: 1 location
1
UMCG
Groningen, Netherlands, 9715BS
Actively Recruiting
Research Team
M
Michiel Rienstra, Prof. dr.
CONTACT
N
Nick L van Vreeswijk, Drs.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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