Comparing AF ablation and medication for treating atrial fibrillation in patients with atrial cardiomyopathy
Atrial Fibrillation (AF) Ablation to Prevent Disease Progression of AF-induced Atrial Cardiomyopathy in Women and Men
This study is testing whether a procedure called AF ablation works better than medication for treating atrial fibrillation in older patients with a specific heart condition.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 604 (estimated) |
| Ages | 65 Years to 80 Years |
| Sex | All |
| Sponsor | University Medical Center Groningen Academic / other |
| Locations | 1 site (Groningen) |
| Trial ID | NCT06200311 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of atrial fibrillation (AF) ablation versus pharmacological rhythm management in patients with atrial cardiomyopathy (ACMP). It focuses on patients aged 65-80 years with confirmed ACMP and ECG-confirmed AF, assessing whether AF ablation can reduce the incidence of cardiovascular death and hospitalizations. The trial is multicenter and utilizes mobile health applications for follow-up, allowing for remote monitoring and data collection. With a total of 604 participants and a median follow-up of 2.5 years, the study seeks to provide insights into the best management strategies for this patient population.
Who should consider this trial
Good fit: Ideal candidates are patients aged 65-80 years with confirmed atrial cardiomyopathy and ECG-confirmed atrial fibrillation.
Not a fit: Patients with longstanding persistent or permanent atrial fibrillation, or those with severe comorbidities, may not benefit from this study.
Why it matters
Potential benefit: If successful, this trial could significantly improve treatment outcomes and quality of life for patients with atrial fibrillation and atrial cardiomyopathy.
How similar studies have performed: Other studies have shown promising results with AF ablation in similar patient populations, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Groningen
- Umcg — Groningen, Netherlands (Recruiting)
Study contacts
- Principal investigator: Michiel Rienstra, Prof. dr. — University Medical Center Groningen
- Study coordinator: Michiel Rienstra, Prof. dr.
- Email: m.rienstra@umcg.nl
- Phone: +31503616161
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.