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

Launched by SHANGHAI CHEST HOSPITAL · Jun 13, 2024

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ClinConnect Summary

This clinical trial is looking at two different methods for a treatment called alcohol ablation, which is used to help patients with atrial fibrillation or atrial flutter—a type of irregular heartbeat. The researchers want to see if using an Over-the-wire (OTW) balloon is more effective and safe compared to using a microcatheter when treating a specific vein in the heart known as the Vein of Marshall. Participants in the study will be randomly assigned to receive either the OTW balloon treatment or the microcatheter treatment, and the outcomes will be compared to understand which method works better.

To be eligible for this study, participants need to be between 18 and 80 years old and have persistent atrial fibrillation or flutter that has not responded well to medications. They should also have a certain level of heart function. However, those with allergies to alcohol or a recent history of serious heart problems, like a heart attack or stroke, will not be able to join the trial. If you choose to participate, you can expect to receive one of the two treatments and help researchers gather important information about how these methods compare.

Gender

ALL

Eligibility criteria

• 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