NCT05794386 SCAR Burden of Left Atrium Guided cathEter Ablation sTrategy for Persistent Atrial Fibrillation
| NCT ID | NCT05794386 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Seoul National University Hospital |
| Condition | Atrial Fibrillation |
| Study Type | INTERVENTIONAL |
| Enrollment | 204 participants |
| Start Date | 2023-02-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 204 participants in total. It began in 2023-02-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a multicenter, randomized controlled trial to compare the recurrence of 1-year atrial arrhythmia after catheter ablation of atrial fibrillation (AF) between pulmonary vein isolation (PVI) and PVI with additional left atrial (LA) substrate modification based on the left atrial low-voltage area (LA LVA) in patients with persistent AF who had a moderate burden of LVA in LA (1cm2 to \<30%).
Eligibility Criteria
Ages eligible for the study: 19 years or older Inclusion criteria: 1. Patients with symptomatic persistent AF who undergo AF catheter ablation due to continued AF even after anti-arrhythmic agents or 2. Patients with a burden of LA LVA (scar zone) of 1cm2 or more and less than 30% in 3D voltage mapping before the index catheter ablation are included in the randomized assignment group when performing catheter ablation in satisfaction with 1) 4\) Patients with an LVA of \<1cm2 or ≥30% are recruited as a registry. Exclusion criteria: 1. Patients with LA anteroposterior diameter of more than 55 mm 2. Patients with prior AF-related catheter ablation or surgery 3. Patients whose exact LVA burden cannot be calculated because high-quality 3D voltage mapping cannot be obtained during the procedure. 4. Inability or unwillingness to receive anticoagulation (heparin or oral anticoagulation) 5. Known severe left ventricular systolic dysfunction (ejection fraction \<35%) 6. Patients with severe structural heart disease (severe mitral regurgitation, hypertrophy cardiomyopathy, other severe valvular heart diseases) 7. Patients with intracardiac thrombus 8. Patients with prior cardiac surgery 9. Patients who had a myocardial infarction or underwent percutaneous coronary intervention within three months 10. Patients who had a stroke or transient ischemic attack within 6 months 11. Patients who had a planned operation or procedure for the cardiovascular system 12. Patients with intractable hypertension or uncontrolled thyroid disease 13. Patients who need dialysis due to end-stage renal disease or who are scheduled for dialysis 14. Patients who are currently pregnant or are likely to be pregnant within the study period 15. Patients who are taking immunosuppressive drugs or had undergone chemotherapy for cancer, autoimmune disease, transplant, etc 16. Patients whose life expectancy is less than 1 year
Contact & Investigator
Eue-Keun Choi, MD, PhD
STUDY CHAIR
Seoul National University Hospital
Frequently Asked Questions
Who can join the NCT05794386 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, studying Atrial Fibrillation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05794386 currently recruiting?
Yes, NCT05794386 is actively recruiting participants. Contact the research team at choiek417@gmail.com for enrollment information.
Where is the NCT05794386 trial being conducted?
This trial is being conducted at Seoul, South Korea.
Who is sponsoring the NCT05794386 clinical trial?
NCT05794386 is sponsored by Seoul National University Hospital. The principal investigator is Eue-Keun Choi, MD, PhD at Seoul National University Hospital. The trial plans to enroll 204 participants.
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