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

Not Applicable

Recruiting

• Conditions: Persistent Atrial Fibrillation; Longstanding Persistent Atrial Fibrillation
• Interventions: Procedure: Vein of Marshall ethanol infusion

• Registration Number: NCT05652517
• Lead Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Brief Summary

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

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 Timeline

• Study First Submitted: 2022-11-28
• Status Verified: 2022-12
• Study Start: 2022-12
• Study First Submitted QC: 2022-12-14
• Last Update Submitted: 2022-12-14
• Study First Posted: 2022-12-15
• Last Update Posted: 2022-12-15
• Primary Completion: 2024-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
UNIVU-guided VOMEI	Vein of Marshall ethanol infusion	Vein of Marshall ethanol infusion guided by CARTO UNIVU and fluoroscopy
Fluoroscopy-guided VOMEI	Vein of Marshall ethanol infusion	Vein of Marshall ethanol infusion guided by fluoroscopy alone

Primary Outcome Measures

Name	Time	Method
Recurrence of atrial tachyarrhythmias	3 to 12 months	Including recurrence of atrial fibrillation, atrial flutter, and atrial tachycardia
Changes of low-voltage or scar area before and after VOMEI	During the procedure	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
Procedural complications	within 72 hours	Including cardiac tamponade, stroke, systemic embolism, major bleeding, acute coronary syndrome, acute heart failure, and death.

Secondary Outcome Measures

Name	Time	Method
New low-voltage or scar area outside mitral isthmus and left pulmonary ridge	During the procedure	New low-voltage or scar area after VOMEI outside the targeted regions
Rates of VOMEI incomplete	During the procedure	Any reason leading to incomplete VOMEI
Rates of intraprocedural termination of atrial fibrillation (not achieved by cardioversion)	During the procedure	Termination of atrial fibrillation without cardioversion
Burden of atrial tachyarrhythmia	12 months	Evaluation by Holder monitoring at 12 months
Rates of mitral isthmus block	During the procedure	bidirectional block of mitral isthmus
X ray exposure time	During the procedure	Procedure-related temporal parameters
radiofrequency ablation time	During the procedure	Procedure-related temporal parameters
procedure time	During the procedure	Procedure-related temporal parameters
Recurrence of atrial flutter	3 to 12 months	recurrence of atrial flutter \> 30 second by ECG or Holder monitoring
Volume of ethanol and contrast agent used	During the procedure	ethanol volume, contrast agent volume used during the procedure

Trial Locations

Locations (1)

Xinhua hospital, Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, China