Actively Recruiting
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)
Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2023-12-11
436
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether radiofrequency catheter ablation (RFCA) is better than antiarrhythmic drugs (AADs) for patients who have atrial fibrillation (AF) and heart failure with preserved ejection fraction (HFpEF). This study focuses on patients already receiving optimized anti-heart-failure drug therapy and aims to compare their long-term clinical outcomes. The trial is international, prospective, multi-center, and randomized, designed to provide clear evidence in this patient group. Participants will be randomly assigned to one of two groups: one group will receive RFCA, a procedure involving a specialized catheter to isolate pulmonary veins and modify heart tissue to control AF, while the other group will receive medical therapy with AADs like amiodarone or dronedarone, following current guidelines including rhythm or rate control. Before randomization, participants undergo a 5-week run-in period where heart failure treatments and anticoagulation are optimized. The follow-up period lasts up to 2 to 3 years after enrollment. During the study, participants will have physical exams, echocardiograms, blood tests including NT-proBNP levels, and quality of life assessments at various times. Researchers will monitor hospitalizations due to worsening heart failure, urgent visits, cardiovascular death, and changes in heart function and symptoms. The main outcome is the time to first event of worsening heart failure or cardiovascular death. The study also tracks walking ability, heart rhythm, and medication changes over time to evaluate overall health and treatment impact.
CONDITIONS
Brief Title
Catheter Ablation in Atrial Fibrillation Patients With HFpEF (STABLE-SR IV Trial)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Symptomatic paroxysmal or persistent atrial fibrillation
- CHADS2-VASc score of 2 or higher
- Diagnosed with heart failure with preserved ejection fraction (HFpEF) including:
- NYHA class II to IV
- Left ventricular ejection fraction of 50% or higher
- NT-proBNP level of 300 pg/mL or higher during sinus rhythm, or 600 pg/mL or higher during atrial fibrillation or flutter
- Echocardiogram showing left ventricular diastolic dysfunction or raised filling pressure
- Signed informed consent
You will not qualify if you...
- Life expectancy less than 2 years due to non-cardiac conditions
- Reversible atrial fibrillation caused by conditions like hyperthyroidism or low potassium
- Previous atrial fibrillation ablation
- Left atrial size 55 mm or larger
- Heart failure due to genetic hypertrophic cardiomyopathy, infiltrative cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, constrictive pericarditis, active myocarditis, cardiac tamponade, or untreated primary valvular disease
- Previous heart transplant, complex congenital heart disease, or rheumatic heart disease
- Contraindications to catheter ablation, antiarrhythmic drugs, or anticoagulation
- Recent acute coronary syndrome, cardiac surgery, angioplasty, or stroke within 12 weeks
- Severe liver or kidney dysfunction
- Body mass index over 50 kg/m2
- Pregnant or breastfeeding women
- Any condition making study completion unlikely
- Participation in other studies
- NT-proBNP below set thresholds after run-in period
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 5 weeks (±7 days)
Participants undergo a run-in period during which anticoagulation and anti-heart-failure therapy are optimized according to current guidelines before randomization.
Visits as needed during run-in period
Duration - Up to 3 years
Participants are randomized to either receive radiofrequency catheter ablation or medical therapy with antiarrhythmic drugs to manage atrial fibrillation.
Visits according to treatment protocol and follow-up schedule
Duration - Up to 3 years
Participants are monitored for clinical outcomes including heart failure events and cardiovascular health after treatment.
Regular follow-up visits throughout study duration
Trial Site Locations
Total: 1 location
1
the First Affiliated Hospital of Nanjing Medical University
Nanjing, China
Actively Recruiting
Research Team
H
Hailei Liu, PhD
N
Nan Wu, MD
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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