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Catheter Ablation for Atrial Fibrillation in Non-Fluoroscopic Lab
Sponsor: Sir Run Run Shaw Hospital
Summary
This randomized controlled trial investigates the efficacy and safety of atrial fibrillation (AF) catheter ablation performed in non-fluoroscopic electrophysiology (EP) labs compared to conventional fluoroscopic digital subtraction angiography labs. The trial hypothesizes non-inferiority in outcomes, with the added benefits of simplified lab environment. Up to 724 participants aged 18-80 with paroxysmal or persistent AF will be enrolled across 10 centers. Participants will be randomized (1:1) to undergo catheter ablation in non-fluoroscopic or fluoroscopic labs, using pulmonary vein isolation (PVI) as the primary ablation strategy. The primary endpoints are freedom from AF recurrence at 12 months and composite safety outcomes related to procedure. Secondary endpoints mainly include procedure duration, recurrence during the initial 90 days, incidence of peri-procedural complications and changes in quality-of-life forms.
Official title: Efficacy and Safety of Catheter Ablation for Atrial Fibrillation in Non-Fluoroscopic Cardiac Electrophysiology Lab: A Non-Inferior, Multi-Center, Prospective Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
724
Start Date
2025-04-22
Completion Date
2028-05-31
Last Updated
2026-02-02
Healthy Volunteers
No
Conditions
Interventions
AF ablation
The primary ablation strategy for both groups will be pulmonary vein isolation (PVI). Other additional ablation, including but not limited to linear ablation, complex fractionated atrial electrogram (CFAE) ablation, or superior vena cava (SVC) isolation is not recommended unless necessitated by one of the following: * Documented atrial flutter (AFL) or atrial tachycardia (AT) observed during the procedure, or * Arrhythmias originating from the specific region requiring intervention.
AF ablation in a non-fluoroscopic EP lab
This procedure will take place in a non-fluoroscopic lab.
AF ablation in a fluoroscopic lab
This procedure will take place in a fluoroscopic lab.
Locations (1)
Sir Run Run Shaw Hospital
Hangzhou, Zhejiang, China