Comparing catheter ablation and drug therapy for atrial fibrillation in heart failure patients
Catheter Ablation in Atrial Fibrillation Patients With Heart Failure With Preserved Ejection Fraction: an International, Prospective, Multi-center, Randomized Controlled Study (STABLE-SR IV Trial)
This study is testing whether a heart procedure called catheter ablation works better than medication for people with atrial fibrillation and heart failure.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 436 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | The First Affiliated Hospital with Nanjing Medical University Academic / other |
| Locations | 1 site (Nanjing) |
| Trial ID | NCT06125925 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates whether radiofrequency catheter ablation (RFCA) is more effective than antiarrhythmic drugs (AADs) for patients with atrial fibrillation (AF) and heart failure with preserved ejection fraction (HFpEF). The study is a prospective, multi-center, randomized controlled trial that aims to assess long-term clinical outcomes in these patients. Participants will undergo a run-in period of optimized anti-heart-failure therapy before being randomized to receive either RFCA or AADs. The trial will evaluate various clinical parameters, including echocardiograms and blood tests, to determine the efficacy of the interventions.
Who should consider this trial
Good fit: Ideal candidates include symptomatic patients with paroxysmal or persistent atrial fibrillation and a diagnosis of HFpEF.
Not a fit: Patients with reversible atrial fibrillation or those with a life expectancy below two years due to non-cardiovascular conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for patients with atrial fibrillation and heart failure, potentially improving their long-term health outcomes.
How similar studies have performed: Previous studies have shown RFCA to be superior to AADs in heart failure patients with reduced ejection fraction, but this specific approach in HFpEF patients is still being explored.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Symptomatic paroxysmal or persistent atrial fibrillation * CHADS2-VASc score≥ 2 * Conform to the diagnosis of HFpEF 1. NYHA II-IV level; 2. Left ventricular ejection fraction (LVEF)≥ 50%; 3. NT-proBNP≥ 300 pg/mL under sinus rhythm or NT-proBNP≥ 600 pg/mL under atrial fibrillation or flutter; 4. Evidence of left ventricular diastolic dysfunction/raised left ventricular filling pressure on echocardiogram. * Sign informed consent Exclusion Criteria: * A life expectancy below 2 years due to any non-cardiovascular condition * Reversible atrial fibrillation, such as hyperthyroidism or hypokalemia-related atrial fibrillation * Prior atrial fibrillation ablation * Left atrial size≥ 55 mm * Heart failure due to any of the following: known genetic hypertrophic cardiomyopathy, infiltrative cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, constrictive pericarditis, active myocarditis, cardiac tamponade, or uncorrected primary valvular disease * Previous cardiac transplantation, complex congenital heart disease, rheumatic heart disease * Any contraindication for radiofrequency catheter ablation, antiarrhythmic drugs or anticoagulation * Acute coronary syndrome, cardiac surgery, angioplasty or cerebrovascular accident within 12 weeks before enrollment * Severe hepatic and renal dysfunction * Body mass index\> 50 kg/m2 * Female in period of pregnancy or breast-feeding * Any conditions that, in the opinion of the investigator, may render the patient unable to complete the study * Involved in other studies The inclusion and exclusion criteria would be reassessed after run-in period and the cut-off of NT-proBNP would be set as \>125 pg/ml under sinus rhythm or \>365 pg/ml under AF/atrial flutter (AFL).
Where this trial is running
Nanjing
- the First Affiliated Hospital of Nanjing Medical University — Nanjing, China (Recruiting)
Study contacts
- Study coordinator: Hailei Liu, PhD
- Email: liuhailei@njmu.edu.cn
- Phone: +86-18094226858
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.