Ireland
--:--IST
Recruiting Not applicable

SCAR Burden of Left Atrium Guided cathEter Ablation sTrategy for Persistent Atrial Fibrillation

NCT05794386 · tracked via the Priya Life Science South Korea tracker
Phase
Not applicable
Started
2023-02-01
Last updated
2026-04-28

Condition(s) studied

Atrial Fibrillation

Investigational drug(s) / intervention(s)

LVA-guided LA substrate modification

LVA-guided LA substrate modification: The LVA-guided additional LA ablation is included linear ablation or LVA zone border modification/isolation/ homogenization. The additional ablation strategies are finally selected at the physicians' discretion, considering LVA location and distribution.

Study 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

Sex
ALL
Min age
19 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Late recurrence of AT/AF — From 3 months to 1 year after the catheter ablation
    Recurrence of atrial tachyarrhythmia (AT/AF) from 3 months to 1 year after the index procedure

Trial sites (1)

FacilityCityRegionStatus
Seoul National University Hospital Seoul Jongno-gu Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05794386 on ClinicalTrials.gov ↗ ← All trials in South Korea