Comparing catheter ablation techniques for persistent atrial fibrillation
SCAR Burden of Left Atrium Guided cathEter Ablation sTrategy for Persistent Atrial Fibrillation (SCARLET-AF Study)
This study is testing whether adding a specific heart procedure to the standard treatment can help people with persistent atrial fibrillation have fewer episodes of irregular heartbeats.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 204 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Seoul National University Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Seoul, Jongno-gu) |
| Trial ID | NCT05794386 on ClinicalTrials.gov |
What this trial studies
This multicenter, randomized controlled trial aims to evaluate the effectiveness of two catheter ablation strategies for patients with persistent atrial fibrillation (AF). Participants will be randomly assigned to receive either pulmonary vein isolation (PVI) alone or PVI combined with left atrial substrate modification based on low-voltage areas. The study will assess the recurrence of atrial arrhythmias over a one-year follow-up period, utilizing statistical methods such as Kaplan-Meier survival analysis and Cox proportional hazard regression. The goal is to determine if the additional substrate modification can reduce AF recurrence compared to standard PVI.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 19 and older with symptomatic persistent atrial fibrillation and a moderate burden of left atrial low-voltage area.
Not a fit: Patients with a left atrial anteroposterior diameter greater than 55 mm or those who have previously undergone AF-related catheter ablation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved outcomes for patients with persistent atrial fibrillation by reducing the recurrence of arrhythmias after catheter ablation.
How similar studies have performed: Other studies have shown promise in catheter ablation techniques for atrial fibrillation, but this specific approach of combining PVI with substrate modification is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Seoul, Jongno-gu
- Seoul National University Hospital — Seoul, Jongno-gu, South Korea (Recruiting)
Study contacts
- Study coordinator: Eue-Keun Choi, MD, PhD
- Email: choiek417@gmail.com
- Phone: 2-2072-0688
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.