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

Shanghai Jiao Tong University

Status: Enrolling

Conditions: Persistent Atrial Fibrillation; Longstanding Persistent Atrial Fibrillation

Treatments: Procedure: Vein of Marshall ethanol infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT05652517

XH-22-009

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Fluoroscopy-guided VOMEI

Active Comparator group

Description:

Vein of Marshall ethanol infusion guided by fluoroscopy alone

Treatment:

Procedure: Vein of Marshall ethanol infusion

UNIVU-guided VOMEI

Experimental group

Description:

Vein of Marshall ethanol infusion guided by CARTO UNIVU and fluoroscopy

Treatment:

Procedure: Vein of Marshall ethanol infusion