Actively Recruiting
Catheter Ablation in Atrial Fibrillation Patients With HFpEF (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
155 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To investigate whether RFCA is superior to AADs in AF patients with HFpEF on the basis of optimized anti-heart-failure drug therapy regarding their longterm clinical outcomes.
CONDITIONS
Official 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
- Diagnosis of heart failure with preserved ejection fraction (HFpEF) confirmed by:
- New York Heart Association (NYHA) class II to IV
- Left ventricular ejection fraction (LVEF) of 50% or higher
- NT-proBNP level of 300 pg/mL or more during normal heart rhythm, or 600 pg/mL or more during atrial fibrillation or flutter
- Evidence of left ventricular diastolic dysfunction or raised filling pressure on echocardiogram
- Signed informed consent
You will not qualify if you...
- Life expectancy less than 2 years due to non-cardiovascular conditions
- Reversible atrial fibrillation causes such as hyperthyroidism or low potassium
- Previous atrial fibrillation ablation
- Left atrial size 55 mm or larger
- Heart failure due to specific heart diseases including genetic hypertrophic cardiomyopathy, infiltrative cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, constrictive pericarditis, active myocarditis, cardiac tamponade, or untreated primary valve disease
- Previous heart transplant, complex congenital heart disease, or rheumatic heart disease
- Contraindications to catheter ablation, antiarrhythmic drugs, or anticoagulation
- Acute coronary syndrome, heart surgery, angioplasty, or stroke within 12 weeks before enrollment
- Severe liver or kidney dysfunction
- Body mass index greater than 50 kg/m2
- Pregnant or breastfeeding females
- Any condition making completion of the study unlikely as judged by the investigator
- Participation in other clinical studies
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
N
Nan Wu, MD
CONTACT
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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