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

Launched by XINHUA HOSPITAL, SHANGHAI JIAO TONG UNIVERSITY SCHOOL OF MEDICINE · Dec 14, 2022

Keywords

ClinConnect Summary

The Marshall-Merge clinical trial is studying two different methods for guiding a specific heart treatment called the Vein of Marshall ethanol infusion (VOMEI). This treatment is aimed at patients with persistent or longstanding persistent atrial fibrillation (AF), a condition where the heart beats irregularly. The trial will compare the traditional way of guiding this procedure using X-ray imaging (fluoroscopy) with a new method called UNIVU. Researchers are looking for participants aged 18 to 85 who have not had previous heart procedures to treat their AF and are willing to undergo this treatment.

If you decide to participate, you'll be randomly assigned to one of the two methods, but you won't know which one you receive. You’ll be closely monitored throughout the study to ensure your safety and well-being. However, there are some important criteria to keep in mind. For instance, you cannot participate if you have certain heart conditions, recent heart surgery, a history of blood clots, or if you're pregnant. Overall, this trial seeks to find out which method works better for helping patients manage their atrial fibrillation effectively.

Gender

ALL

Eligibility criteria

• 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