Heart Rhythm Procedure Tested in Labs Without Routine X-ray Imaging
Tests catheter ablation for irregular heartbeat in adults with atrial fibrillation.
Plain-language title generated from the registry record
Registry title: Catheter Ablation for Atrial Fibrillation in Non-Fluoroscopic Lab
Key facts
- Where
- Hangzhou, ChinaSee the site
Where in China
- Sir Run Run Shaw HospitalHangzhou, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Sir Run Run Shaw Hospital
- Trial code
- NCT06719921
- Record updated
- 20 August 2026
- Original description
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.Read full original descriptionShow less
Efficacy and Safety of Catheter Ablation for Atrial Fibrillation in Non-Fluoroscopic Cardiac Electrophysiology Lab: A Non-Inferior, Multi-Center, Prospective Randomized Controlled Trial
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.
Inclusion: 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.
Exclusion: Serious known concomitant disease with a life expectancy of < 1 year; Current enrollment in an investigational study evaluating another device or drug; Patients with contraindication to right or left sided cardiac catheterization; 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; Acute illness, active systemic infection, or sepsis; LVEF<30%; Patients with contraindication to anticoagulation; X-ray fluoroscopy is required in the procedure, such as ablation combined with VOM ethanol ablation, epicardial ablation, LAAO, CAG, etc; MI, CABG, or PCI within the preceding 3 months; Left atrial diameter >55 mm; NYHA class III or IV; Significant congenital anomaly or a medical problem that in the opinion of the investigator would preclude enrollment in this trial.