Image Fusion of Integrating Fluoroscopy Into 3D Computed Tomography in Guidance of Vein of Marshall Ethanol Infusion During Persistent Atrial Fibrillation Ablation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Recurrence of atrial tachyarrhythmias
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Recurrence of atrial tachyarrhythmias
时间窗: 3 to 12 months
Including recurrence of atrial fibrillation, atrial flutter, and atrial tachycardia
Changes of low-voltage or scar area before and after VOMEI
时间窗: During the procedure
Left atrial voltage mapping will be performed before and after VOMEI. The low-voltage area or scar area will be mesured and compared before and after VOMEI
Procedural complications
时间窗: within 72 hours
Including cardiac tamponade, stroke, systemic embolism, major bleeding, acute coronary syndrome, acute heart failure, and death.
次要结局
- New low-voltage or scar area outside mitral isthmus and left pulmonary ridge(During the procedure)
- Rates of VOMEI incomplete(During the procedure)
- Rates of intraprocedural termination of atrial fibrillation (not achieved by cardioversion)(During the procedure)
- Burden of atrial tachyarrhythmia(12 months)
- Rates of mitral isthmus block(During the procedure)
- X ray exposure time(During the procedure)
- radiofrequency ablation time(During the procedure)
- procedure time(During the procedure)
- Recurrence of atrial flutter(3 to 12 months)
- Volume of ethanol and contrast agent used(During the procedure)
研究者
Jian Sun
Principal investigator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine