Comparing AF ablation and medication for treating atrial fibrillation in patients with atrial cardiomyopathy
Official title: Atrial Fibrillation (AF) Ablation to Prevent Disease Progression of AF-induced Atrial Cardiomyopathy in Women and Men
Run by University Medical Center Groningen · NCT06200311 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 65 Years to 80 Years |
| Sex | All |
| Enrollment | 604 (estimated) |
| Sponsor | University Medical Center Groningen Academic / other |
| Locations | 1 site (Groningen) |
| Status | Recruiting |
| Started | July 25, 2024 |
| Main results expected | July 25, 2029 |
| Study ends | July 25, 2029 |
| Registry record updated | October 18, 2024 |
| Trial ID | NCT06200311 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients aged 65-80 years with confirmed atrial cardiomyopathy and ECG-confirmed atrial fibrillation.
✕Probably not a fit
Patients with longstanding persistent or permanent atrial fibrillation, or those with severe comorbidities, may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Other studies have shown promising results with AF ablation in similar patient populations, suggesting potential for success in this approach.
Who can join: the full rules
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 it's running
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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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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BDNF Levels and Atrial Cardiomyopathy in People Having AF Ablation
This study tests whether circulating BDNF levels are linked to atrial cardiomyopathy in adults having their first ablation for persistent atrial fibrillation.
-
AI-assisted echocardiography to predict outcomes in left atrial cardiomyopathy
This will try whether AI-assisted echocardiography speeds up atrial strain measurements and whether those strain changes help predict atrial fibrillation and in-hospital complications in adults in a cardiac care unit.
-
Long-term outcomes for patients with cardiac arrhythmias
This study looks at how well treatments for heart rhythm problems work over time and what factors might affect their success for patients with conditions like atrial fibrillation and ventricular tachycardia.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.