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)
Status: Recruiting
Location: See location...
Intervention Type: Procedure, Drug
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
China
the First Affiliated Hospital of Nanjing Medical University
RECRUITING
Nanjing
Contact Information
Primary
Hailei Liu, PhD
liuhailei@njmu.edu.cn
+86-18094226858
Backup
Nan Wu, MD
wunannjmu@163.com
+86-18351977986
Time Frame
Start Date: 2023-11-06
Estimated Completion Date: 2026-11
Participants
Target number of participants: 436
Treatments
Experimental: 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.
Active_comparator: 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.
Related Therapeutic Areas
Sponsors
Leads: The First Affiliated Hospital with Nanjing Medical University