AF ablationAF ablation in a non-fluoroscopic EP labAF ablation in a fluoroscopic lab
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 ( a lab without a fluoroscopy system).
AF ablation in a fluoroscopic lab: This procedure will take place in a fluoroscopy-equipped lab.
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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Age: ≥18 years
2. Patients diagnosed with paroxysmal AF or persistent AF with a duration of 1 years or less, who are referred for catheter ablation.
3. Patients referred for catheter ablation as a first-time intervention (no prior catheter ablation or surgical procedures for AF).
4. The patient is able and willing to provide written informed consent.
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 VOM ethanol 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 the investigator would preclude enrollment in this trial.
Primary outcome measure(s)
Freedom from Documented AF Without Antiarrhythmic Drugs at 12 Months Post-Ablation — From enrollment to the end of treatment at 12 months The primary endpoint of the study is treatment success from the end of the 90-day blanking period through 12 months after the index procedure. Treatment failure is defined as documented AF, atrial flutter, or atrial tachycardia lasting \>30 seconds; continuation or reinitiation of a class I or III AAD after the blanking period; or electrical cardioversion after the blanking period; or repeat catheter ablation for any atrial arrhythmia at any time of follow-up, including during the blanking period. Ablation performed solely for typical right atrial flutter or other supraventricular tachycardia will not constitute treatment failure.
Incidence of Composite Procedure-Related Serious Adverse Events at 3 Months Post-Ablation — From enrollment to the end of treatment at 3 months The primary safety endpoint is a composite of the following prespecified procedure-related serious adverse events:
* Major vascular complication or major bleeding within the first 7 days post procedure.
* Development of a clinically significant pericardial effusion.
* Transient ischemic attack.
* Stroke.
* Myocardial infarction.
* Sinus node dysfunction or high-grade atrioventricular block within 30 days.
* Severe pulmonary vein stenosis.
* Atrial-esophageal fistula, or phrenic nerve injury within 3 months.
* Death.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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