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

Last updated: December 14, 2022
Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Overall Status: Active - Recruiting

Phase

N/A

Condition

Arrhythmia

Chest Pain

Atrial Fibrillation

Treatment

N/A

Clinical Study ID

NCT05652517
XH-22-009
  • Ages 18-85
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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, systemicembolism
  • 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

Total Participants: 100
Study Start date:
December 01, 2022
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • Xinhua hospital, Shanghai Jiao Tong University School of Medicine

    Shanghai, 200092
    China

    Active - Recruiting

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