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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06460831
• Other study ID #: MARSHALL-CATH study
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 15, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2024
• Source: Shanghai Chest Hospital
• Contact: Xu Liu, MD
• Phone: +8618101817225
• Email: drliuxu[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 800
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Flutter

Intervention

Device:
• Microcatheter
The microcatheter group undergoes alcohol ablation using a microcatheter.
• OTW
The OTW group undergoes alcohol ablation using an OTW balloon.

Locations

Country	Name	City	State
China	Changshu Hospital of Traditional Chinese Medical	Changshu
China	Shandong University of Traditional Chinese Medicine	Jinan	Shandong
China	Ren Ji Hospital	Shanghai	Shanghai
China	Shanghai Chest Hospital	Shanghai	Shanghai
China	Yuhuan Second People's Hospital	Taizhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Chest Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute rate of mitral isthmus block	Efficacy endpoints	During catheter ablation procedures
Primary	Procedural complications	Safety endpoints	During catheter ablation procedures
Primary	Recovery rate of the mitral isthmus line	Long-term primary efficacy endpoints	beyond 3 months after the ablation procedure.
Secondary	Procedural characteristics		Periprocedural period
Secondary	Hospitalization costs		Periprocedural period