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
NCT06460831 ยท Status: NOT_YET_RECRUITING ยท Phase: NA ยท Type: INTERVENTIONAL ยท Enrollment: 800
Last updated 2024-06-14
Summary
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: โข 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.
Conditions
- Atrial Fibrillation
- Atrial Flutter
Interventions
- DEVICE
-
Microcatheter
The microcatheter group undergoes alcohol ablation using a microcatheter.
- DEVICE
-
OTW
The OTW group undergoes alcohol ablation using an OTW balloon.
Sponsors & Collaborators
-
Shanghai Chest Hospital
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-06-15
- Primary Completion
- 2024-12-31
- Completion
- 2024-12-31
Countries
- China
Study Locations
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