RECRUITINGINTERVENTIONAL

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

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)

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form Who Should NOT Join This Trial: - 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). Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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).

Treatments Being Tested

PROCEDURE

Radiofrequency catheter ablation (RFCA)

Radiofrequency ablation is adopted in the study, instead of cryo ablation, surgical ablation or pulsed field ablation. 3-dimensional model is constructed after transseptal puncture. Circumferential pulmonary vein isolation (CPVI) is performed with irrigated contact force catheter. Previously published STABLE-SR approach is recommended as the ablation strategy beyond CPVI.

DRUG

Medical Therapy

AADs should be prescribed according to the current guidelines, such as amiodarone, dronedarone, or propafenone. In brief, rhythm control is preferred, including electric cardioversion. However, rate control should be considered if rhythm control is contraindicated, intolerated or unpreferred by patients.

Locations (1)

the First Affiliated Hospital of Nanjing Medical University

Nanjing, China