EXPORT Randomized Trial

NCT07197931 | Not Yet Recruiting DMC

• 1 other identifier: 2025-1476-001
• Study Type: interventional
• Target: 406
• Locations: 1 country
• Sites: 1

Brief Summary

Pulmonary Vein Isolation (PVI)-Only Group

• 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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Recurrence of atrial arrhythmia

  any documented atrial arrhythmia lasting ≥30 seconds after a 3-month blanking period following ablation with or without the use of antiarrhythmic drug use

  within 24 months after enrollement

Secondary Outcomes (5)

• Recurrence of atrial arrhythmia or use of antiarrhythmic drug

  within 24 months after enrollement

• Recurrence of atrial fibrillation

  within 24 months after enrollement

• Recurrence of atrial tachycardia/flutter

  within 24 months after enrollement

• Cardioversion rate

  within 24 months after enrollement

• Complication rate

  within 24 months after enrollement

Study Arms (2)

Additional extra-pulmonary vein trigger ablation group

EXPERIMENTAL

circumferential pulmonary vein isolation with additive induction, mapping, and ablation of non-pulmonary vein trigger

Procedure: Additional extra-pulmonary vein trigger ablation group

Empirical pulmonary vein isolation group

ACTIVE COMPARATOR

circumferential pulmonary vein isolation only

Procedure: Empirical pulmonary vein isolation group

Interventions

Additional extra-pulmonary vein trigger ablation group PROCEDURE

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.

Additional extra-pulmonary vein trigger ablation group

Empirical pulmonary vein isolation group PROCEDURE

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.

Empirical pulmonary vein isolation group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged ≥19 years with persistent atrial fibrillation scheduled for catheter ablation.
• Refractory to or intolerant of at least one Class I or III antiarrhythmic drug.
• Undergoing first-time catheter ablation for atrial fibrillation.

You may not qualify if:

• Acute coronary syndrome within the past 3 months.
• Severe unrevascularized coronary artery disease: ≥70% stenosis in at least one major epicardial vessel with a diameter ≥2 mm.
• History of stroke or transient ischemic attack (TIA) within the past 3 months.
• Uncontrolled severe hypertension (systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥120 mmHg).
• Severe untreated aortic valve stenosis.
• Symptomatic moderate-to-severe valvular heart disease.
• Aortic dissection.
• Heart failure with reduced ejection fraction (LVEF \<40%).
• Severe pulmonary hypertension (resting RVSP \>60 mmHg).
• Left atrial anteroposterior diameter \>60 mm.
• Presence of cyanotic congenital heart disease.
• Obstructive hypertrophic cardiomyopathy (resting or provoked LVOT pressure gradient ≥30 mmHg).
• History of prior maze surgery or catheter ablation for atrial fibrillation.
• Active internal bleeding.
• Contraindications to anticoagulation therapy or rhythm control treatment.

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Severance Cardiovascular Hospital, Yonsei University Health System

Seoul, 120-752, South Korea

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2025
• First Posted: September 30, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): August 31, 2029
• Study Completion (Estimated): August 31, 2030
• Last Updated: September 30, 2025

Record last verified: 2025-09

Locations

KR (1)