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

NCT05652517 | Unknown

• 1 other identifier: XH-22-009
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Persistent Atrial Fibrillation; Longstanding Persistent Atrial Fibrillation

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (10)

• Rates of mitral isthmus block

  During the procedure

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

  During the procedure

• Rates of VOMEI incomplete

  During the procedure

• X ray exposure time

  During the procedure

• procedure time

  During the procedure

Study Arms (2)

Fluoroscopy-guided VOMEI

ACTIVE COMPARATOR

Vein of Marshall ethanol infusion guided by fluoroscopy alone

Procedure: Vein of Marshall ethanol infusion

UNIVU-guided VOMEI

EXPERIMENTAL

Vein of Marshall ethanol infusion guided by CARTO UNIVU and fluoroscopy

Procedure: Vein of Marshall ethanol infusion

Interventions

Vein of Marshall ethanol infusion PROCEDURE

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

Fluoroscopy-guided VOMEI; UNIVU-guided VOMEI

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Xinhua hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, 200092, China

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jian Sun

  Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mu Chen, MD

CONTACT

021-25077287; chenmu@xinhuamed.com.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: November 28, 2022
• First Posted: December 15, 2022
• Study Start: December 1, 2022
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2025
• Last Updated: December 15, 2022

Record last verified: 2022-12

Locations

CN (1)