Overview
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.
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.
Eligibility
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