Comparing catheter ablation and lifestyle changes for treating atrial fibrillation
Catheter Ablation vs. Antiarrhythmic Drugs and Risk Factor Modification. PRAGUE-25 Randomized Study
This study is testing whether making lifestyle changes and taking medication can help people with atrial fibrillation as effectively as catheter ablation.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 212 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Charles University, Czech Republic Academic / other |
| Locations | 1 site (Prague) |
| Trial ID | NCT04011800 on ClinicalTrials.gov |
What this trial studies
This trial aims to compare the effectiveness of catheter ablation versus a non-invasive approach involving antiarrhythmic drugs and lifestyle modifications in patients with symptomatic atrial fibrillation. The study will be conducted as a prospective, multicenter, randomized, non-inferiority trial, focusing on patients with a BMI of 30 or higher. Primary outcomes will include the recurrence of atrial fibrillation, while secondary outcomes will assess AF burden, exercise capacity, quality of life, and metabolic changes. The goal is to determine if lifestyle changes can achieve similar rhythm outcomes as catheter ablation.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals with symptomatic atrial fibrillation and a BMI of 30 or higher.
Not a fit: Patients with permanent atrial fibrillation, severe heart conditions, or significant physical limitations may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide an effective non-invasive treatment option for patients with atrial fibrillation, potentially reducing the need for invasive procedures.
How similar studies have performed: While there have been observational studies on lifestyle modifications for atrial fibrillation, this direct comparison of catheter ablation and lifestyle changes is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria (all three must be met): * symptomatic atrial fibrillation * BMI ≥ 30, and * signed informed content Exclusion Criteria: * permanent AF * severe valve disease (significant aortic stenosis, mitral regurgitation ≥ 3) * left ventricular ejection fraction \< 40% * severe pulmonary hypertension (PAP \> 40 mm Hg) * history of tachycardia-induced cardiomyopathy * manifest coronary artery disease * pregnancy * left atrial size ≥ 60 mm * indication for surgical treatment of obesity * BMI ≥ 40 * diabetes mellitus on insulintreatment * age ≥ 75 let * a significant physical limitation that could affect physical activity (musculoskeletal disorders, COPD) * life expectancy less than 2 years
Where this trial is running
Prague
- Cardiocenter, 3rd Medical School, Charles University and University Hospital Kralovske Vinohrady — Prague, Czechia (Recruiting)
Study contacts
- Study coordinator: Pavel Osmancik
- Email: pavel.osmancik@gmail.com
- Phone: 00420721544447
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.