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Comparison of Circumferential Pulmonary Vein (PV) Isolation Alone Versus Additional EXtra-PulmOnaRy Vein Trigger Ablation in Persistent Atrial Fibrillation
Pulmonary Vein Isolation (PVI)-Only Group 1. Pulmonary vein isolation (PVI) will be performed, and the procedure will be terminated without the administration of isoproterenol following the standard waiting period. 2. In cases where spontaneous triggers are observed following PVI, mapping and ablation of the identified triggers are permitted. 3. Post-procedural rhythm monitoring and follow-up will be conducted in accordance with the predefined study protocol. Additional Non-Pulmonary Vein (Non-PV) Trigger Ablation Group Isoproterenol will be administered starting at 5 μg/min, with stepwise increases to 10 μg/min and 20 μg/min at 3-5 minute intervals, as tolerated, aiming to achieve 85% of the maximum predicted heart rate, with a maximum dose of 30 μg/min.The total infusion duration will be at least 10 minutes. * If systolic blood pressure (SBP) decreases by ≥20 mmHg from the baseline (prior to infusion), the isoproterenol infusion will be discontinued. * If hypotension is anticipated or occurs during isoproterenol infusion, phenylephrine infusion may be administered to maintain SBP between 120-140 mmHg. * For patients with a history of coronary artery disease, heart failure, or valvular heart disease, the maximum isoproterenol infusion rate may be limited to ≤10 μg/min at the discretion of the operator.
Details
| Lead sponsor | Yonsei University |
|---|---|
| Phase | NA |
| Status | NOT_YET_RECRUITING |
| Enrolment | 406 |
| Start date | 2025-10 |
| Completion | 2030-08-31 |
Conditions
- Atrial Fibrillation
Interventions
- Additional extra-pulmonary vein trigger ablation group
- Empirical pulmonary vein isolation group
Primary outcomes
- Recurrence of atrial arrhythmia — within 24 months after enrollement
any documented atrial arrhythmia lasting ≥30 seconds after a 3-month blanking period following ablation with or without the use of antiarrhythmic drug use
Countries
South Korea