Catheter Ablation for Atrial Fibrillation in Non-Fluoroscopic Lab

The primary end point of the study is freedom from any documented atrial arrhythmia, including AF, atrial tachycardia or atrial flutter episodes lasting longer than 30 seconds without antiarrhythmic drugs, for 12 months after the index ablation procedure, excluding a 3-month blanking period. The continuation or reinitiation of class I or class III antiarrhythmic drugs after the 3-month post-ablation blanking period, as well as electric cardioversion or catheter ablation for any atrial arrhythmias, are considered treatment failures for the primary end point.

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.

The acute success of the procedure is defined as the percentage of procedures achieving the intended acute procedural endpoints, including: 1) Complete PVI, as confirmed by mapping or pacing maneuvers. 2) Immediate restoration and maintenance of sinus rhythm at the end of the procedure, either spontaneously or through cardioversion.

The percentage of procedures in each group (non-fluoroscopic and conventional DSA lab) that required conversion to X-ray guidance during the ablation procedure. Conversion is defined as the use of fluoroscopy to complete any part of the procedure that could not be accomplished using the assigned guidance modality.

he percentage of patients experiencing recurrence of AF or AFL/AT during the blanking period (90 days post-ablation).

The percentage of patients experiencing complications such as cardiac tamponade, stroke, or vascular complications during the peri-procedural period.

The total time elapsed from the moment of skin puncture to the removal of all catheters and completion of the procedure (skin-to-skin time).

The total time during the procedure when energy was delivered for ablation.

The change in patients' self-reported quality of life related to atrial fibrillation, as measured by the AF Effect on Quality of Life (AFQT) questionnaire. And the change in patients' overall health-related quality of life, as measured by the EQ-5D-3L questionnaire.

The change in patients' overall health-related quality of life, as measured by the EQ-5D-3L questionnaire.

Analysis of the primary and secondary endpoints separately for RFA and PFA. All analyses will be conducted post hoc within the predefined data structure of the parent trial. No additional procedures, study visits, or participant consent are required, as this analysis relies solely on data collected as part of routine protocol-mandated assessments.

This sub-analysis will explore the effect of different blanking period definitions (1-month, 2-month vs 3-month) on arrhythmia-free success rates after PFA, using the same dataset and follow-up schedule as the main study.

It is an exploratory analytical component of the main trial and does not involve separate randomization or data collection.

This sub-analysis will explore whether different time definitions influence the interpretation of 12-month ablation success. Two analytical models will be applied using the main trial dataset without additional interventions or visits:

• Model A (documented AF duration model): Patients will be stratified by AF type (paroxysmal vs. persistent ≤1 year) and analyzed according to documented AF duration based on the first recorded AF episode.
• Model B (symptom/diagnosis-to-ablation interval model): Patients will be stratified according to the interval from initial symptom onset or first AF diagnosis-whichever occurs earlier-to the ablation procedure, with categories defined by the actual distribution of the study population.

This exploratory sub-analysis compares analytical approaches only; it does not modify clinical management, affect randomization, or add data collection requirements.