The goal of this study is to compare OTW balloon with microcatheter in the Marshall vein alcohol ablation study. The main questions it aims to answer are: • Is there a difference in the effectiveness and safety of OTW balloon and microcatheter in Marshall vein alcohol ablation? Participants will be asked to:
Undergo treatment with OTW balloon Undergo treatment with microcatheter If there is a comparison group: Researchers will compare the OTW balloon group and the microcatheter group to see different effects.
Age range: 18-80 years.
Persistent atrial fibrillation or atrial flutter dependent on the mitral isthmus.
Inadequate response to antiarrhythmic drug therapy, or intolerance to antiarrhythmic drugs.
New York Heart Association functional class ≤ IV,with left ventricular ejection fraction (LVEF) ≥ 35%
Patients with known allergies to alcohol.
Participants with a history of serious cardiovascular events such as myocardial infarction or stroke within the past three months will be excluded from the study
Parallel
Microcatheter
DeviceThe microcatheter group undergoes alcohol ablation using a microcatheter.
OTW
DeviceThe OTW group undergoes alcohol ablation using an OTW balloon.
Acute rate of mitral isthmus block
Efficacy endpoints
Procedural complications
Safety endpoints
Recovery rate of the mitral isthmus line
Long-term primary efficacy endpoints
Procedural characteristics
Hospitalization costs
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This trial is not recruiting at the moment. You can still explore other options:
