NCT06460831

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 800 (estimated)
• Sponsor: Shanghai Chest Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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: • 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

Type	Name	Description
DEVICE	Microcatheter	The microcatheter group undergoes alcohol ablation using a microcatheter.
DEVICE	OTW	The OTW group undergoes alcohol ablation using an OTW balloon.

Timeline

• Start date: 2024-06-15
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2024-06-14
• Last updated: 2024-06-14

Locations

5 sites across 1 country: China