Severance Cardiovascular Hospital, Yonsei University Health System
Seoul, 120-752, South Korea
NCT Number: NCT07197931
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.
Trial opening soon.
Get Notified19 year and older
All sexes
Interventional
Not applicable
Seoul, 120-752, South Korea
"A. Essential Standard Pre-Procedural Examinations for Catheter Ablation
B. Administration of Medications Before and After Catheter Ablation
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 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
Time frame: within 24 months after enrollement
any documented atrial arrhythmia lasting ≥30 seconds after a 3-month blanking period following ablation or the use of antiarrhythmic drug use
Time frame: within 24 months after enrollement
any documented atrial fibrillation lasting ≥30 seconds after a 3-month blanking period following ablation with or without the use of antiarrhythmic drug use
Time frame: within 24 months after enrollement
any documented atrial tachycardia/flutter lasting ≥30 seconds after a 3-month blanking period following ablation with or without the use of antiarrhythmic drug use
Time frame: within 24 months after enrollement
any cardioversion performed following ablation
Time frame: within 24 months after enrollement
any complication related to ablation
Yonsei University
Other
Comparison of Circumferential Pulmonary Vein (PV) Isolation Alone Versus Additional EXtra-PulmOnaRy Vein Trigger Ablation in Persistent Atrial Fibrillation
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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