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

NCT05794386 | Recruiting DMC

• 1 other identifier: SCARLET-AF
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 1

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%).

Conditions

Atrial Fibrillation

Keywords

Atrial fibrillation; Catheter ablation

Outcome Measures

Primary Outcomes (1)

• Late recurrence of AT/AF

  Recurrence of atrial tachyarrhythmia (AT/AF) from 3 months to 1 year after the index procedure

  From 3 months to 1 year after the catheter ablation

Secondary Outcomes (5)

• Early recurrence of atrial tachyarrhythmia

  Within 3 months from the catheter ablation

• Late recurrence of AF

  From 3 months to 1 year after the catheter ablation

• Late recurrence of AT

  From 3 months to 1 year after the catheter ablation

• Maintenance of Sinus Rhythm and AF/AT burden

  After 1 year after index procedure

• AF-related Quality of Life

  Before (at baseline) and after (at 1 year) the catheter ablation

Study Arms (2)

PVI only group

NO INTERVENTION

Patients will receive PVI alone regardless of LVA burden.

Additional LA substrate modification group

EXPERIMENTAL

Patients will receive PVI plus additional LA substrate modification according to their LVA burden.

Procedure: LVA-guided LA substrate modification

Interventions

LVA-guided LA substrate modification PROCEDURE

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.

Additional LA substrate modification group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, Jongno-gu, 03080, South Korea

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Study Officials

• Eue-Keun Choi, MD, PhD

  Seoul National University Hospital

  STUDY CHAIR

Central Study Contacts

Eue-Keun Choi, MD, PhD

CONTACT

2-2072-0688; choiek417@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This is a 1:1 randomized controlled trial.

Study Record Dates

• First Submitted: March 20, 2023
• First Posted: April 3, 2023
• Study Start: February 1, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 28, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)