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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
800
The microcatheter group undergoes alcohol ablation using a microcatheter.
The OTW group undergoes alcohol ablation using an OTW balloon.
Shandong University of Traditional Chinese Medicine
Jinan, Shandong, China
Ren Ji Hospital
Shanghai, Shanghai Municipality, China
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China
Yuhuan Second People's Hospital
Taizhou, Zhejiang, China
Changshu Hospital of Traditional Chinese Medical
Changshu, China
Acute rate of mitral isthmus block
Efficacy endpoints
Time frame: During catheter ablation procedures
Procedural complications
Safety endpoints
Time frame: During catheter ablation procedures
Recovery rate of the mitral isthmus line
Long-term primary efficacy endpoints
Time frame: beyond 3 months after the ablation procedure.
Procedural characteristics
Time frame: Periprocedural period
Hospitalization costs
Time frame: Periprocedural period
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