RecruitingNot ApplicableNCT05794386

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

SCAR Burden of Left Atrium Guided cathEter Ablation sTrategy for Persistent Atrial Fibrillation (SCARLET-AF Study)

Sponsor

Seoul National University Hospital

Enrollment

204 participants

Start Date

Feb 1, 2023

Study Type

INTERVENTIONAL

Conditions

Atrial Fibrillation

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

Min Age: 19 Years

Inclusion Criteria4

Ages eligible for the study: 19 years or older
Patients with symptomatic persistent AF who undergo AF catheter ablation due to continued AF even after anti-arrhythmic agents or
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)
\) Patients with an LVA of \<1cm2 or ≥30% are recruited as a registry.

Exclusion Criteria16

Patients with LA anteroposterior diameter of more than 55 mm
Patients with prior AF-related catheter ablation or surgery
Patients whose exact LVA burden cannot be calculated because high-quality 3D voltage mapping cannot be obtained during the procedure.
Inability or unwillingness to receive anticoagulation (heparin or oral anticoagulation)
Known severe left ventricular systolic dysfunction (ejection fraction \<35%)
Patients with severe structural heart disease (severe mitral regurgitation, hypertrophy cardiomyopathy, other severe valvular heart diseases)
Patients with intracardiac thrombus
Patients with prior cardiac surgery
Patients who had a myocardial infarction or underwent percutaneous coronary intervention within three months
Patients who had a stroke or transient ischemic attack within 6 months
Patients who had a planned operation or procedure for the cardiovascular system
Patients with intractable hypertension or uncontrolled thyroid disease
Patients who need dialysis due to end-stage renal disease or who are scheduled for dialysis
Patients who are currently pregnant or are likely to be pregnant within the study period
Patients who are taking immunosuppressive drugs or had undergone chemotherapy for cancer, autoimmune disease, transplant, etc
Patients whose life expectancy is less than 1 year

Interventions

PROCEDURELVA-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.