Comparing two methods for guiding ethanol infusion in atrial fibrillation treatment
Image Fusion of Integrating Fluoroscopy Into 3D Computed Tomography in Guidance of Vein of Marshall Ethanol Infusion During Persistent Atrial Fibrillation Ablation
This study is testing two different ways to guide a treatment for atrial fibrillation to see which one works better and is safer for patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Xinhua Hospital, Shanghai Jiao Tong University School of Medicine Academic / other |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT05652517 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a prospective, randomized, single-blind study that aims to compare two methods for guiding Vein of Marshall ethanol infusion (VOMEI) in patients with persistent or longstanding persistent atrial fibrillation. Participants will be randomly assigned to receive VOMEI either through conventional fluoroscopy guidance or through a combination of fluoroscopy and CARTO UNIVU guidance. The study will evaluate the efficacy of the procedures by measuring changes in low-voltage areas and will assess safety by monitoring procedural complications. Long-term outcomes will focus on the recurrence of atrial tachyarrhythmia over a period of 3 to 12 months.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 85 with persistent or longstanding persistent atrial fibrillation who are willing to undergo catheter ablation and VOMEI.
Not a fit: Patients with recent cardiac events, significant comorbidities, or contraindications to anticoagulation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the effectiveness and safety of atrial fibrillation treatments, potentially leading to better patient outcomes.
How similar studies have performed: While the specific approach of using UNIVU guidance for VOMEI is novel, similar studies have shown promise in improving procedural outcomes in atrial fibrillation treatments.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Shanghai
- Xinhua hospital, Shanghai Jiao Tong University School of Medicine — Shanghai, China (Recruiting)
Study contacts
- Principal investigator: Jian Sun — Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Study coordinator: Mu Chen, MD
- Email: chenmu@xinhuamed.com.cn
- Phone: 021-25077287
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.