Univu-guided Vein of Marshall Ethanol Infusion (Marshall-Merge)
China100 participantsStarted 2022-12
Plain-language 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.
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Changes of low-voltage or scar area before and after VOMEI
Timeframe: During the procedure
2
Procedural complications
Timeframe: within 72 hours
3
Recurrence of atrial tachyarrhythmias
Timeframe: 3 to 12 months
Trial details
NCT IDNCT05652517
SponsorXinhua Hospital, Shanghai Jiao Tong University School of Medicine