Circumferential pulmonary vein isolation (CPVI) with adjunctive linear ablation vs. CPVI alone for long-standing persistent atrial fibrillation (SINUS): study protocol for a prospective, multi-center, randomized controlled trial

Abstract

Previous studies have shown that circumferential pulmonary vein isolation (CPVI) alone has a relatively lower success rate for long-standing persistent atrial fibrillation (LSPAF). This study aims to compare the efficacy and safety between CPVI combined with modified linear ablation (CPVI-MLA) and CPVI alone in patients with LSPAF. This (SINUS) study is a prospective, multi-center, randomized controlled trial for treatment of LSPAF. Patients ( n = 320) with LSPAF are being randomized to either CPVI-MLA or CPVI alone group in 1:1 ratio. The CPVI-MLA protocol consists of (1) ethanol infusion in the vein of Marshall; (2) complete CPVI; (3) extended lesion sets (posterior wall isolation, dual isthmus ablation); and (4) substrate modification (left atrial intima adjoining coronary sinus (LAI-CS) and superior vena cava isolation (SVCI)). 24-h Holter monitoring is being performed at the 1st and 3rd month follow-up visits, with 3-day Holter monitoring being performed at the 6th, 9th, and 12th month follow-up visits. The primary endpoint is freedom from atrial tachyarrhythmias (≥ 30 s) after the initial 3-month blanking period post-index ablation without any antiarrhythmic drug support for 12 months. This (SINUS) study will evaluate the efficacy and safety of CPVI-MLA strategy as compared to CPVI alone in patients with LSPAF. ClinicalTrials.gov NCT06516822. First submitted that met QC criteria: July 23, 2024.