Catheter Ablation in Atrial Fibrillation Patients With HFpEF (STABLE-SR IV Trial)

• Status: Recruiting
• Trial end date: 2026-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

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).