NCT07197931

EXPORT Randomized Trial

Comparison of Circumferential Pulmonary Vein (PV) Isolation Alone Versus Additional EXtra-PulmOnaRy Vein Trigger Ablation in Persistent Atrial Fibrillation

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 406 (estimated)
• Sponsor: Yonsei University · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

"A. Essential Standard Pre-Procedural Examinations for Catheter Ablation * Transthoracic Echocardiography (TTE): Performed in all patients to evaluate the presence of structural heart disease, left atrial size, and left ventricular function. Findings guide the selection of antiarrhythmic medications and assist in determining procedural indications. * Transesophageal or Intracardiac Echocardiography: Conducted in all patients prior to the procedure to detect thrombi within the left atrial appendage, thereby minimizing the risk of post-procedural cerebrovascular events. * Three-Dimensional Cardiac CT Imaging (substitutable with Cardiac Magnetic Resonance Imaging if clinically indicated): Performed in all patients before the procedure to generate a three-dimensional anatomical model of the left atrium by integrating voltage mapping and contour data from CT images. This approach enhances procedural accuracy and reduces the incidence of procedure-related complications. * The most recent test results prior to the procedure should be utilized preferentially; in the absence of recent data, prior examination results may be used as substitutes. B. Administration of Medications Before and After Catheter Ablation * Anticoagulant therapy will be administered for a period of one month prior to and for a minimum of two months following the catheter ablation procedure, in order to reduce the risk of thromboembolic events, including stroke. Should the risk of stroke remain elevated due to atrial fibrillation recurrence or other clinical considerations, continuation of anticoagulation therapy may be determined at the discretion of the treating physician. * In cases where recurrence of atrial fibrillation is suspected, or if there is a clinically assessed high likelihood of recurrence, antiarrhythmic medications may be prescribed based on the clinical judgment of the physician.

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-10-01
• Primary completion: 2029-08-31
• Completion: 2030-08-31
• First posted: 2025-09-30
• Last updated: 2025-09-30

Locations

1 site across 1 country: South Korea