Comparing catheter ablation techniques for persistent atrial fibrillation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.