SCAR Burden of Left Atrium Guided cathEter Ablation sTrategy for Persistent Atrial Fibrillation
Recruiting · NCT05794386 · Interventional (participants receive a specific treatment) · Lead sponsor: Seoul National University Hospital
View the official record on ClinicalTrials.gov →Interventions studied
LVA-guided LA substrate modification
What this trial is about
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%).
Who can take part
Age range
19 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- 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
Where it is running
1 location listed.
- Seoul National University Hospital - Seoul, Jongno-gu, South Korea