NCT06719921Enrolling by invitation
Catheter Ablation for Atrial Fibrillation in Non-Fluoroscopic Lab
Efficacy and Safety of Catheter Ablation for Atrial Fibrillation in Non-Fluoroscopic Cardiac Electrophysiology Lab: A Non-Inferior, Multi-Center, Prospective Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 20 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Interventional
- Enrollment
- 724 (estimated)
- First submitted
- 26 Nov 2024
- Start date
- 22 Apr 2025
- Primary completion date
- 30 Apr 2028
- Lead sponsor
- Sir Run Run Shaw Hospital
- Diseases
- Atrial fibrillation
- NCT number
- NCT06719921
What you commit to
- Study type: Interventional
- Planned participants: 724
- From 22 Apr 2025 to the primary completion date, 30 Apr 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Serious known concomitant disease with a life expectancy of \< 1 year
- Current enrollment in an investigational study evaluating another device or drug.
Other illness
- 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.
Lab values
- LVEF\<30%
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sir Run Run Shaw Hospital Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.