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

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine100 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

100

Conditions

Persistent Atrial Fibrillation Longstanding Persistent Atrial Fibrillation

Interventions

Vein of Marshall ethanol infusionPROCEDURE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (1)

Xinhua hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, China

RECRUITING

Outcomes

Primary Outcomes

Changes of low-voltage or scar area before and after VOMEI

Left atrial voltage mapping will be performed before and after VOMEI. The low-voltage area or scar area will be mesured and compared before and after VOMEI

Time frame: During the procedure

Procedural complications

Including cardiac tamponade, stroke, systemic embolism, major bleeding, acute coronary syndrome, acute heart failure, and death.

Time frame: within 72 hours

Recurrence of atrial tachyarrhythmias

Including recurrence of atrial fibrillation, atrial flutter, and atrial tachycardia

Time frame: 3 to 12 months

Secondary Outcomes

Rates of mitral isthmus block

bidirectional block of mitral isthmus

Time frame: During the procedure

New low-voltage or scar area outside mitral isthmus and left pulmonary ridge

New low-voltage or scar area after VOMEI outside the targeted regions

Time frame: During the procedure

Rates of VOMEI incomplete

Any reason leading to incomplete VOMEI

Time frame: During the procedure

X ray exposure time

Procedure-related temporal parameters

Time frame: During the procedure

procedure time

Procedure-related temporal parameters

Central Contacts

Mu Chen, MD

CONTACT

021-25077287 chenmu@xinhuamed.com.cn

Data from ClinicalTrials.gov

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