Status:
NOT_YET_RECRUITING
EXPORT Randomized Trial
Lead Sponsor:
Yonsei University
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
19+ years
Phase:
NA
Brief 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 ...
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 a...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- Presence of severe comorbid conditions or life expectancy \<1 year.
- Drug or alcohol abuse.
- Pregnancy.
- Any other condition that, in the investigator's judgment, makes the patient unsuitable for study participation.
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2030
Estimated Enrollment :
406 Patients enrolled
Trial Details
Trial ID
NCT07197931
Start Date
October 1 2025
End Date
August 31 2030
Last Update
September 30 2025
Active Locations (1)
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1
Severance Cardiovascular Hospital, Yonsei University Health System
Seoul, South Korea, 120-752