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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorShanghai Chest Hospital

About this trial

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.

Eligibility criteria

Qualifiers

Age range: 18-80 years.

Persistent atrial fibrillation or atrial flutter dependent on the mitral isthmus.

Inadequate response to antiarrhythmic drug therapy, or intolerance to antiarrhythmic drugs.

New York Heart Association functional class ≤ IV,with left ventricular ejection fraction (LVEF) ≥ 35%

Disqualifiers

Patients with known allergies to alcohol.

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

Treatments tested in this trial

  • Microcatheter
  • OTW

Treatment groups

800 Participants
are divided into 2 treatment groups

Sponsors and collaborators