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

Not Applicable

Not yet recruiting

• Conditions: Atrial Flutter; Atrial Fibrillation
• Interventions: Device: OTW; Device: Microcatheter

• Registration Number: NCT06460831
• Lead Sponsor: Shanghai Chest Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-06-04
• Study First Submitted QC: 2024-06-13
• Last Update Submitted: 2024-06-13
• Study First Posted: 2024-06-14
• Last Update Posted: 2024-06-14
• Study Start: 2024-06-15
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 800

Inclusion Criteria

1. Age range: 18-80 years.
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

1. Patients with known allergies to alcohol.
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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OTW group	OTW	-
Microcatheter group	Microcatheter	-

Primary Outcome Measures

Name	Time	Method
Recovery rate of the mitral isthmus line	beyond 3 months after the ablation procedure.	Long-term primary efficacy endpoints
Acute rate of mitral isthmus block	During catheter ablation procedures	Efficacy endpoints
Procedural complications	During catheter ablation procedures	Safety endpoints

Secondary Outcome Measures

Name	Time	Method
Hospitalization costs	Periprocedural period
Procedural characteristics	Periprocedural period

Trial Locations

Locations (5)

Ren Ji Hospital; 🇨🇳 Shanghai, Shanghai, China

Shandong University of Traditional Chinese Medicine; 🇨🇳 Jinan, Shandong, China

Shanghai Chest Hospital; 🇨🇳 Shanghai, Shanghai, China

Yuhuan Second People's Hospital; 🇨🇳 Taizhou, Zhejiang, China

Changshu Hospital of Traditional Chinese Medical; 🇨🇳 Changshu, China