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Univu-guided Vein of Marshall Ethanol Infusion (Marshall-Merge)

NCT ID: NCT05652517

Last Updated: 2022-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-31

Study Completion Date

2025-12-31

Brief Summary

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The study is a prospective, randomized, single-blind clinical trial aiming to compare two method in guidance of Vein of Marshall ethanol infusion (VOMEI), i.e., the conventional fluoroscopy-guided VOMEI and UNIVU-guided VOMEI.

Detailed Description

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A total of 100 participants with persistent or longstanding persistent AF who undergo radiofrequency catheter ablation will be randomized assigned to two groups at 1:1 ratio to receive Vein of Marshall ethanol infusion (VOMEI).

Group 1: VOMEI guided by fluroscopy alone Group 2: VOMEI guided by fluoroscopy and CARTO UNIVU The intraprocedural major endpoints are the change in low-voltage area led by VOMEI (efficacy endpoint) and procedural complications (safety endpoint). The longterm major endpoint is the recurrence of atrial tachyarrhythmia between 3 and 12 months.

Conditions

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Persistent Atrial Fibrillation Longstanding Persistent Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Fluoroscopy-guided VOMEI

Vein of Marshall ethanol infusion guided by fluoroscopy alone

Group Type ACTIVE_COMPARATOR

Vein of Marshall ethanol infusion

Intervention Type PROCEDURE

Vein of Marshall ethanol infusion performed during the radiofrequency catheter ablation of persistent or long-standing persistent atrial fibrillation.

UNIVU-guided VOMEI

Vein of Marshall ethanol infusion guided by CARTO UNIVU and fluoroscopy

Group Type EXPERIMENTAL

Vein of Marshall ethanol infusion

Intervention Type PROCEDURE

Vein of Marshall ethanol infusion performed during the radiofrequency catheter ablation of persistent or long-standing persistent atrial fibrillation.

Interventions

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Vein of Marshall ethanol infusion

Vein of Marshall ethanol infusion performed during the radiofrequency catheter ablation of persistent or long-standing persistent atrial fibrillation.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Age between 18 and 85 years
* Sympathetic atrial fibrillation without previous ablation
* Persistent or long-standing persistent AF
* Patients' willing to undergo catheter ablation and VOMEI

Exclusion Criteria

* Left atrial or left atrial appendage thrombus
* LVEF \<30%
* Cardiac surgery within 90 days
* Myocardial infarction within 90 days
* PCI or PTCA within 90 days
* Thromboembolic events within 90 days, including stroke, pulmonary embolism, systemic embolism
* Atrial myxoma
* Congenital heart disease
* Pregnant or pregnant plan
* Acute or severe infection
* Creatine\> 221 μmol/L, or GFR \<30 ml/min/1.73 m.
* Unstable angina
* Blood-clotting or bleeding disorder
* Contraindication to anticoagulation
* Life expectancy less than 1 year
* Uncontrolled heart failure
* Uncontrolled malignant tumor
* Malformation of femoral vascular access
* Without consent
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Jian Sun

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jian Sun

Role: PRINCIPAL_INVESTIGATOR

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Locations

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Xinhua hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Mu Chen, MD

Role: CONTACT

Phone: 021-25077287

Email: [email protected]

Facility Contacts

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Jian Sun

Role: primary

Other Identifiers

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XH-22-009

Identifier Type: -

Identifier Source: org_study_id