RecruitingNot ApplicableNCT06125925

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)

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Enrollment

436 participants

Start Date

Nov 6, 2023

Study Type

INTERVENTIONAL

Conditions

Atrial Fibrillation HFpEF - Heart Failure With Preserved Ejection Fraction

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.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria8

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 Criteria13

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

Interventions

PROCEDURERadiofrequency 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.

DRUGMedical 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.