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

NCT06460831 | Not Yet Recruiting DMC

• 1 other identifier: MARSHALL-CATH study
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Atrial Fibrillation; Atrial Flutter

Keywords

marshall vein; mitral valve isthmus line

Outcome Measures

Primary Outcomes (3)

• Acute rate of mitral isthmus block

  Efficacy endpoints

  During catheter ablation procedures

• Procedural complications

  Safety endpoints

  During catheter ablation procedures

• Recovery rate of the mitral isthmus line

  Long-term primary efficacy endpoints

  beyond 3 months after the ablation procedure.

Secondary Outcomes (2)

• Procedural characteristics

  Periprocedural period

• Hospitalization costs

  Periprocedural period

Study Arms (2)

OTW group

PLACEBO COMPARATOR

Device: OTW

Microcatheter group

EXPERIMENTAL

Device: Microcatheter

Interventions

Microcatheter DEVICE

The microcatheter group undergoes alcohol ablation using a microcatheter.

Microcatheter group

OTW DEVICE

The OTW group undergoes alcohol ablation using an OTW balloon.

OTW group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Chest Hospital: lead

Study Sites (5)

Shandong University of Traditional Chinese Medicine

Jinan, Shandong, 250000, China

Location

Ren Ji Hospital

Shanghai, Shanghai Municipality, 200030, China

Location

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

Location

Yuhuan Second People's Hospital

Taizhou, Zhejiang, 318000, China

Location

Changshu Hospital of Traditional Chinese Medical

Changshu, 215500, China

Location

MeSH Terms

Conditions

Atrial Fibrillation; Atrial Flutter

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Xu Liu, MD

CONTACT

+8618101817225; drliuxu@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of the Arrhythmia Center

Study Record Dates

• First Submitted: June 4, 2024
• First Posted: June 14, 2024
• Study Start: June 15, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: June 14, 2024

Record last verified: 2024-06

Locations

CN (5)