EXPORT Randomized Trial

NANot yet recruitingINTERVENTIONAL
Enrollment

406

Participants

Timeline

Start Date

October 31, 2025

Primary Completion Date

August 31, 2029

Study Completion Date

August 31, 2030

Conditions
Atrial Fibrillation
Interventions
PROCEDURE

Additional extra-pulmonary vein trigger ablation group

"1. Circumferential PVI is performed in all patients.~2. After PVI, isoproterenol is infused starting at 5 μg/min, increased every 3-5 min to 10 and 20 μg/min (max 30 μg/min) to reach 85% of predicted heart rate for ≥10 min.~ 2-1) If AF persists, internal cardioversion (5-30 J) is performed using catheters in the right atrium and coronary sinus.~ 2-2) If sinus rhythm is present, a 15-beat drive train (10 mA, 2 ms) is delivered at 250 ms, shortened by 10 ms to 180 ms or until capture fails, up to three times, to induce AF or AT. Isoproterenol continues for 2 min. If arrhythmia occurs, cardioversion is repeated.~3. After cardioversion, isoproterenol is stopped and the patient is observed for 10 min.~4. Sustained or reproducible arrhythmias are defined as non-PV triggers.~5. These are localized with activation mapping, P-wave analysis, and high-density mapping.~6. Ablation is performed with the same catheter.~7. Reassessment is done with the same protocol."

PROCEDURE

Empirical pulmonary vein isolation group

"1. Circumferential pulmonary vein isolation (PVI) is performed in all patients.~2. After PVI, a waiting period of at least 20 minutes is observed, followed by reassessment of pulmonary vein isolation before concluding the procedure.~3. Additional linear ablation or CFAE ablation not specified in the study protocol should be avoided whenever possible.~4. In cases where typical atrial flutter has been documented prior to the procedure or is induced during the procedure, cavo-tricuspid isthmus (CTI) ablation is performed. At the operator's discretion, CTI ablation may also be permitted even in patients without a prior history or inducibility.~5. If atypical atrial flutter involving these pathways is induced during the procedure, additional linear ablation (e.g., roof line, posterior-inferior line, left lateral isthmus, or anterior line) may be performed."

Trial Locations (1)

120-752

Severance Cardiovascular Hospital, Yonsei University Health System, Seoul

All Listed Sponsors
lead

Yonsei University

OTHER

NCT07197931 - EXPORT Randomized Trial | Biotech Hunter | Biotech Hunter