Prospective Single-centre Study to Evaluate the Feasibility of Ethanolization of Vein of Marshall With a Specific Catheter in the Ablation of Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Acute success rate of the procedure
研究概览
简要总结
In patients with persistent AF (PsAF), ablation limited to pulmonary vein (PV) isolation is the most straightforward approach, but results only in 50% of arrhythmia freedom at 1 year follow-up. Substrate modification strategies have failed to demonstrate their superiority with variable reported success rate. The Marshall network is a highly arrhythmogenic structure that has not been systematically targeted so far, probably because of the absence of dedicated tools to make its ablation simple and easy. We sought to investigate the use of a specific catheter for visualization and ethanolization of vein of Marshall allowing to systematically include this target in the ablation set.
The main objective of this study is to demonstrate the feasibility to use the Targeted Endovascular Delivery (TED) catheter specifically for visualization and ethanolization of vein of Marshall.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Suitable candidate for catheter ablation of atrial fibrillation defined as:
- •history of symptomatic persistent atrial fibrillation
- •Redo procedure for persistent AF or paroxysmal AF with isolated PV and no history of ethanol infusion in the VOM.
- •Age > 18 years of both genders
- •Patient affiliated or beneficiary of social security scheme
- •Free, informed and written consent signed by the participant and the principal investigator (at least at the inclusion date and before all exams required for the clinical research)
- •Effective contraception for women of childbearing potential
排除标准
- •Documented left atrial thrombus or another abnormality which precludes catheter introduction
- •Contraindication to anticoagulation therapy (heparin, warfarin, or novel oral anticoagulant [NOAC]
- •Contraindication to iodinated contrast product XENETIX® (iobitridol hypersensivity or at one of these excipients, history of major immediate reaction or cutaneous reaction to XENETIX® infusion, thyrotoxicosis)
- •Hypersensitivity to ethanol
- •Unstable angina or ongoing myocardial ischemia
- •Myocardial infarction within 3 months prior to inclusion
- •Congenital heart disease, where the underlying abnormality increases the ablation risk
- •Severe bleeding, clotting or thrombotic disorder
- •Pregnant, parturient or nursing women
- •Unable or unwilling to provide written informed consent
- •Patient detained by judicial or administrative order
- •Patient under psychiatric care
- •Patient admitted in a social or healthcare establishment for any purpose other than the research
- •Subject to a legal protection order (guardianship, patient under legal protection)
结局指标
主要结局
Acute success rate of the procedure
时间窗: 12 months
Success rate complete realization of ethanolization procedure
次要结局
- Total duration of ethanolization procedure(12 months)
- Total X Ray duration and radiation dose(12 months)
- Incidence of Vein of Marshall dissection(12 months)
- Time to visualization of Vein of Marshall(12 months)
- Duration of balloon positioning(12 months)
- Incidence of complications related to catheter(12 months)
- Incidence of periprocedural complications related to ethanolization(12 months)