Catheter Ablation for Atrial Fibrillation in Non-Fluoroscopic Lab

Enrolling by invitation · Not applicable

Conditions studied: Atrial Fibrillation (AF)

In brief

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.

Key facts

Study ID

NCT06719921

Run by

Sir Run Run Shaw Hospital

People needed

724

Starts

2025-04-22

Expected to finish

2028-05-31

Last updated by the study team

2026-02-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age: ≥18 years
• Patients diagnosed with paroxysmal AF or persistent AF with a duration of 1 years or less, who are referred for catheter ablation.
• Patients referred for catheter ablation as a first-time intervention (no prior catheter ablation or surgical procedures for AF).
• The patient is able and willing to provide written informed consent.

You may not qualify if…

• Patients with contraindication to anticoagulation
• Patients with contraindication to right or left sided cardiac catheterization
• X-ray fluoroscopy is required in the procedure, such as ablation combined with VOM ethanol ablation, epicardial ablation, LAAO, CAG, etc.
• Serious known concomitant disease with a life expectancy of < 1 year
• MI, CABG, or PCI within the preceding 3 months
• Left atrial diameter >55 mm
• LVEF<30%
• NYHA class III or IV
• Awaiting cardiac transplantation or other cardiac surgery within 12 months.
• History of a documented thromboembolic event within the past 6 weeks.
• Heart or vascular malformation that impedes catheter access or vascular puncture.
• Current enrollment in an investigational study evaluating another device or drug.
• Acute illness, active systemic infection, or sepsis.
• Significant congenital anomaly or a medical problem that in the opinion of the investigator would preclude enrollment in this trial.

Where it is running

• Sir Run Run Shaw Hospital — Hangzhou, Zhejiang, China

Full record on ClinicalTrials.gov

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