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

June 13, 2024 updated by: Xu Liu, Shanghai Chest Hospital

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

800

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Changshu, China, 215500
        • Changshu Hospital of Traditional Chinese Medical
        • Contact:
    • Shandong
      • Jinan, Shandong, China, 250000
        • Shandong University of Traditional Chinese Medicine
        • Contact:
    • Shanghai
      • Shanghai, Shanghai, China, 200030
        • Shanghai Chest Hospital
        • Contact:
      • Shanghai, Shanghai, China, 200030
        • Ren Ji Hospital
        • Contact:
    • Zhejiang
      • Taizhou, Zhejiang, China, 318000
        • Yuhuan Second People's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: OTW group
Device: OTW
The OTW group undergoes alcohol ablation using an OTW balloon.
Experimental: Microcatheter group
Device: Microcatheter
The microcatheter group undergoes alcohol ablation using a microcatheter.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute rate of mitral isthmus block
Time Frame: During catheter ablation procedures
Efficacy endpoints
During catheter ablation procedures
Procedural complications
Time Frame: During catheter ablation procedures
Safety endpoints
During catheter ablation procedures
Recovery rate of the mitral isthmus line
Time Frame: beyond 3 months after the ablation procedure.
Long-term primary efficacy endpoints
beyond 3 months after the ablation procedure.

Secondary Outcome Measures

Outcome Measure
Time Frame
Procedural characteristics
Time Frame: Periprocedural period
Periprocedural period
Hospitalization costs
Time Frame: Periprocedural period
Periprocedural period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Chest Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 15, 2024

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

June 4, 2024

First Submitted That Met QC Criteria

June 13, 2024

First Posted (Actual)

June 14, 2024

Study Record Updates

Last Update Posted (Actual)

June 14, 2024

Last Update Submitted That Met QC Criteria

June 13, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MARSHALL-CATH study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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