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

Shanghai Jiao Tong University

Status: Not yet enrolling

Conditions: Atrial Flutter; Atrial Fibrillation

Treatments: Device: Microcatheter; Device: OTW

Study type: Interventional

Funder types: Other

Identifiers

NCT06460831

MARSHALL-CATH study

Details and patient eligibility

About

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.

Enrollment: 800 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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800 participants in 2 patient groups, including a placebo group

OTW group

Placebo Comparator group

Treatment:

Device: OTW

Microcatheter group

Experimental group

Treatment:

Device: Microcatheter