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

Image Fusion of Integrating Fluoroscopy Into 3D Computed Tomography in Guidance of Vein of Marshall Ethanol Infusion During Persistent Atrial Fibrillation Ablation

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.

Study Overview

• Status: Recruiting
• Conditions: Persistent Atrial Fibrillation; Longstanding Persistent Atrial Fibrillation
• Intervention / Treatment: Procedure: Vein of Marshall ethanol infusion

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mu Chen, MD; Phone Number: 021-25077287; Email: chenmu@xinhuamed.com.cn

Study Locations

• China
  • Shanghai, China, 200092
    • Recruiting
    • Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
    • Contact: Jian Sun; Email: sunjian@xinhuamed.com.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 81 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Fluoroscopy-guided VOMEI; Vein of Marshall ethanol infusion guided by fluoroscopy alone	Procedure: Vein of Marshall ethanol infusion; Vein of Marshall ethanol infusion performed during the radiofrequency catheter ablation of persistent or long-standing persistent atrial fibrillation.
Experimental: UNIVU-guided VOMEI; Vein of Marshall ethanol infusion guided by CARTO UNIVU and fluoroscopy	Procedure: Vein of Marshall ethanol infusion; Vein of Marshall ethanol infusion performed during the radiofrequency catheter ablation of persistent or long-standing persistent atrial fibrillation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	During the procedure
Procedural complications	Including cardiac tamponade, stroke, systemic embolism, major bleeding, acute coronary syndrome, acute heart failure, and death.	within 72 hours
Recurrence of atrial tachyarrhythmias	Including recurrence of atrial fibrillation, atrial flutter, and atrial tachycardia	3 to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rates of mitral isthmus block	bidirectional block of mitral isthmus	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	During the procedure
Rates of VOMEI incomplete	Any reason leading to incomplete VOMEI	During the procedure
X ray exposure time	Procedure-related temporal parameters	During the procedure
procedure time	Procedure-related temporal parameters	During the procedure
radiofrequency ablation time	Procedure-related temporal parameters	During the procedure
Rates of intraprocedural termination of atrial fibrillation (not achieved by cardioversion)	Termination of atrial fibrillation without cardioversion	During the procedure
Burden of atrial tachyarrhythmia	Evaluation by Holder monitoring at 12 months	12 months
Recurrence of atrial flutter	recurrence of atrial flutter > 30 second by ECG or Holder monitoring	3 to 12 months
Volume of ethanol and contrast agent used	ethanol volume, contrast agent volume used during the procedure	During the procedure

Collaborators and Investigators

• Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Investigators: Principal Investigator: Jian Sun, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2022
• Primary Completion (Anticipated): December 1, 2024
• Study Completion (Anticipated): December 1, 2025

Study Registration Dates

• First Submitted: November 28, 2022
• First Submitted That Met QC Criteria: December 14, 2022
• First Posted (Actual): December 15, 2022

Study Record Updates

• Last Update Posted (Actual): December 15, 2022
• Last Update Submitted That Met QC Criteria: December 14, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation; Physiological Effects of Drugs; Anti-Infective Agents, Local; Anti-Infective Agents; Central Nervous System Depressants; Ethanol
• Other Study ID Numbers: XH-22-009

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No