Catheter Ablation for Atrial Fibrillation in Non-Fluoroscopic Lab

Last updated: November 20, 2025
Sponsor: Sir Run Run Shaw Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Arrhythmia

Chest Pain

Dysrhythmia

Treatment

AF ablation in a non-fluoroscopic EP lab

AF ablation in a fluoroscopic lab

AF ablation

Clinical Study ID

NCT06719921
邵逸夫医院伦审2025研第0052号
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age: 18 - 80 years

  2. Patients diagnosed with paroxysmal AF or persistent AF with a duration of 3 years orless, who are referred for catheter ablation.

  3. Patients referred for catheter ablation as a first-time intervention (no priorcatheter ablation or surgical procedures for AF).

  4. The patient is able and willing to provide written informed consent.

Exclusion

Exclusion Criteria:

  1. Patients with contraindication to anticoagulation

  2. Patients with contraindication to right or left sided cardiac catheterization

  3. X-ray fluoroscopy is required in the procedure, such as ablation combined with VOMethanol ablation, epicardial ablation, LAAO, CAG, etc.

  4. Serious known concomitant disease with a life expectancy of < 1 year

  5. MI, CABG, or PCI within the preceding 3 months

  6. Left atrial diameter >55 mm

  7. LVEF<30%

  8. NYHA class III or IV

  9. Awaiting cardiac transplantation or other cardiac surgery within 12 months.

  10. History of a documented thromboembolic event within the past 6 weeks.

  11. Heart or vascular malformation that impedes catheter access or vascular puncture.

  12. Current enrollment in an investigational study evaluating another device or drug.

  13. Acute illness, active systemic infection, or sepsis.

  14. Significant congenital anomaly or a medical problem that in the opinion of theinvestigator would preclude enrollment in this trial.

Study Design

Total Participants: 724
Treatment Group(s): 3
Primary Treatment: AF ablation in a non-fluoroscopic EP lab
Phase:
Study Start date:
April 22, 2025
Estimated Completion Date:
May 31, 2028

Study Description

This study evaluates the clinical efficacy and safety of AF catheter ablation procedures in non-fluoroscopic EP labs, compared to fluoroscopy labs. Non-fluoroscopic labs rely on advanced technologies such as three-dimensional electroanatomic mapping system, intracardiac echocardiography (ICE), contact force sensing catheter and/or pulsed field ablation(PFA), etc...

Participants are randomized into two groups:

  1. Non-Fluoroscopic Lab Group: Ablation procedures will utilize 3D mapping systems. ICE is mandatory for real-time anatomical visualization, and fluoroscopy is employed only in unforeseen procedural challenges to ensure patient safety.

  2. Fluoroscopic Lab Group: Procedures are conducted in a fluoroscopic lab using the same tools and mapping system as non-fluoroscopic lab group, with radiation exposure monitored and minimized according to ALARA principles.

The primary efficacy endpoint assesses treatment success at 12 months, defined as freedom from AF, atrial flutter (AFL), or atrial tachycardia (AT) recurrence for more than 30 seconds, as detected by ECG or 7-day Holter. Safety endpoints include a composite of major adverse events such as stroke, tamponade, myocardial infarction, or phrenic nerve injury within 3 months post-procedure. Secondary endpoints focus on procedural metrics, recurrence during the blanking period, adverse event profiles, and changes in quality-of-life forms using the AF Effect on Quality of Life (AFQT) and the EuroQol Health-Related Quality-of-Life 3-Level (EQ-5D-3L) instruments.

Data collection involves electronic data capture (EDC) systems, with detailed peri-procedural and follow-up evaluations at 3, 6, 9, and 12 months. Each participant undergoes quality-of-life assessments, physical exams, and arrhythmia recurrence monitoring via ECG and 7-day Holter recordings.

Connect with a study center

  • Sir Run Run Shaw Hospital

    Hangzhou, Zhejiang 310000
    China

    Site Not Available

  • Sir Run Run Shaw Hospital

    Hangzhou 1808926, Zhejiang 1784764 310000
    China

    Active - Recruiting

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