Status:
RECRUITING
Catheter Ablation in Atrial Fibrillation Patients With HFpEF (STABLE-SR IV Trial)
Lead Sponsor:
The First Affiliated Hospital with Nanjing Medical University
Conditions:
Atrial Fibrillation
HFpEF - Heart Failure With Preserved Ejection Fraction
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
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.
Detailed Description
Background: Atrial Fibrillation (AF) is a common cardiac rhythm disorder and radiofrequency catheter ablation (RFCA) has become the first-line therapy in the symptomatic AF patients. Heart failure is ...
Eligibility Criteria
Inclusion
- Symptomatic paroxysmal or persistent atrial fibrillation
- CHADS2-VASc score≥ 2
- Conform to the diagnosis of HFpEF
- NYHA II-IV level;
- Left ventricular ejection fraction (LVEF)≥ 50%;
- NT-proBNP≥ 300 pg/mL under sinus rhythm or NT-proBNP≥ 600 pg/mL under atrial fibrillation or flutter;
- Evidence of left ventricular diastolic dysfunction/raised left ventricular filling pressure on echocardiogram.
- Sign informed consent
Exclusion
- 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).
Key Trial Info
Start Date :
November 6 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2026
Estimated Enrollment :
436 Patients enrolled
Trial Details
Trial ID
NCT06125925
Start Date
November 6 2023
End Date
November 1 2026
Last Update
December 11 2023
Active Locations (1)
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1
the First Affiliated Hospital of Nanjing Medical University
Nanjing, China