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

Last updated: June 13, 2024
Sponsor: Shanghai Chest Hospital
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Chest Pain

Cardiac Disease

Arrhythmia

Treatment

OTW

Microcatheter

Clinical Study ID

NCT06460831
MARSHALL-CATH study
  • Ages 18-80
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 antiarrhythmicdrugs.

  4. New York Heart Association functional class ≤ IV,with left ventricular ejectionfraction (LVEF) ≥ 35%

Exclusion

Exclusion Criteria:

  1. Patients with known allergies to alcohol.

  2. Participants with a history of serious cardiovascular events such as myocardialinfarction or stroke within the past three months will be excluded from the study

Study Design

Total Participants: 800
Treatment Group(s): 2
Primary Treatment: OTW
Phase:
Study Start date:
June 15, 2024
Estimated Completion Date:
December 31, 2024

Connect with a study center

  • Shandong University of Traditional Chinese Medicine

    Jinan, Shandong 250000
    China

    Site Not Available

  • Ren Ji Hospital

    Shanghai, Shanghai 200030
    China

    Site Not Available

  • Shanghai Chest Hospital

    Shanghai, Shanghai 200030
    China

    Site Not Available

  • Yuhuan Second People's Hospital

    Taizhou, Zhejiang 318000
    China

    Site Not Available

  • Changshu Hospital of Traditional Chinese Medical

    Changshu, 215500
    China

    Site Not Available

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