A Comparative Study Evaluating the Vein of MArshall Ethanol Infusion Ablation Using an Over-the-wire (OTW) Balloon Versus a microcatHeter in Patients With Atrial Fibrillation
NCT ID: NCT06460831
Last Updated: 2024-06-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
800 participants
INTERVENTIONAL
2024-06-15
2024-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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OTW group
OTW
The OTW group undergoes alcohol ablation using an OTW balloon.
Microcatheter group
Microcatheter
The microcatheter group undergoes alcohol ablation using a microcatheter.
Interventions
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Microcatheter
The microcatheter group undergoes alcohol ablation using a microcatheter.
OTW
The OTW group undergoes alcohol ablation using an OTW balloon.
Eligibility Criteria
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Inclusion Criteria
2. Persistent atrial fibrillation or atrial flutter dependent on the mitral isthmus.
3. Inadequate response to antiarrhythmic drug therapy, or intolerance to antiarrhythmic drugs.
4. New York Heart Association functional class ≤ IV,with left ventricular ejection fraction (LVEF) ≥ 35%
Exclusion Criteria
2. 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
18 Years
80 Years
ALL
Yes
Sponsors
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Shanghai Chest Hospital
OTHER
Responsible Party
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Xu Liu
Chief of the Arrhythmia Center
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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MARSHALL-CATH study
Identifier Type: -
Identifier Source: org_study_id
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