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New treatment option for Atrial Fibrillation
Official title SCAR Burden of Left Atrium Guided cathEter Ablation sTrategy for Persistent Atrial Fibrillation
ClinicalTrials.gov ID: NCT05794386
What this study is testing
- What it's testing
- 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%).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 and older
You may be able to join if
- 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...
You likely can't join 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)
See the full eligibility criteria
- 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 assigned by chance assignment group when performing catheter...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Seoul, Jongno-gu, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seoul, Jongno-gu, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.