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

Status

Not yet recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06460831

Enrollment

800

Registered

2024-06-14

Start date

2024-06-15

Completion date

2024-12-31

Last updated

2024-06-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation, Atrial Flutter

Keywords

marshall vein, mitral valve isthmus line

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.

Interventions

DEVICEMicrocatheter

The microcatheter group undergoes alcohol ablation using a microcatheter.

DEVICEOTW

The OTW group undergoes alcohol ablation using an OTW balloon.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Procedural characteristics	Periprocedural period
Hospitalization costs	Periprocedural period

Countries

China

Contacts

Primary ContactXu Liu, MD

drliuxu@126.com+8618101817225

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026