Added Value of Vein of Marshal Ethanol Infusion Compared to Superior Vena Cava Isolation Alone in Patients Undergoing Repeat Ablation for Recurrent Paroxysmal Atrial Fibrillation Despite Durable Pulmonary Vein Isolation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Recurrence of atrial tachyarrhythmia 1 year after the index ablation
研究概览
简要总结
The superior vena cava (SVC) is one of the most common non pulmonary vein (PV)-triggers for atrial tachyarrhythmias. SVC electrical isolation can be reached by circular radiofrequency (RF)-ablation under close monitoring of the phrenic nerve. However, adding substrate modification and vein of Marshal (VoM) ethanol infusion to the ablation procedure might substantially improve long-term outcomes.
The aim of this study is to evaluate the recurrence rate 1 year after the index ablation in patients undergoing a redo ablation for recurrent paroxysmal atrial fibrillation (PAF) despite durable pulmonary vein isolation (PVI) with either SVC isolation alone or with substrate modification including vein of Marshal ethanolisation in addition to SVC isolation alone
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
- 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
- •Patients older than 18 years
- •Patients scheduled for a repeat ablation of PAF after a previous PVI
- •Confirmation of lasting pulmonary vein isolation at the time of randomization
排除标准
- •Patients with persistent atrial fibrillation
- •Previous ablation with isolation of the SVC, roofline, mitral line or previous vein of Marshal ethanol infusion
- •Left atrial thrombus. Left atrial appendage thrombus can be determined by preprocedural imaging: CT, transesophageal echocardiography or MRI.
- •Left ventricular ejection fraction <35%.
- •Cardiac surgery within the previous 90 days.
- •Expecting cardiac transplantation or other cardiac surgery within 180 days.
- •Coronary percutaneous transluminal coronary angioplasty/stenting within the previous 90 days or myocardial infarction within the previous 60 days.
- •Documented history of a thromboembolic event within the previous 90 days.
- •Diagnosed atrial myxoma.
- •Significant restrictive, constrictive, or chronic obstructive pulmonary disease with chronic symptoms.
- •Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment
- •Women who are pregnant or who plan to become pregnant during the study.
- •Acute illness or active infection at time of index procedure
- •Advanced renal insufficiency
- •Unstable angina.
- •History of blood clotting or bleeding abnormalities.
- •Contraindication to anticoagulation.
- •Life expectancy less than 1 year.
- •Presence of a condition that precludes vascular access.
- •International Normalized Ratio greater than 3.5 within 24 hours of procedure - for patients taking warfarin.
- •Patient cannot be removed from antiarrhythmic drugs for reasons other than AF.
- •Unwilling or unable to provide informed consent.
研究组 & 干预措施
SVC isolation with substrate modification and VoM inf
Patients in Group 2 will receive an SVC isolation with substrate modification and vein of Marshal ethanol infusion
干预措施: SVC isolation with substrate modification and vein of Marshal ethanol infusion (Procedure)
SVC only
Patients in Group 1 will receive an SVC isolation only
干预措施: SVC only (Procedure)
结局指标
主要结局
Recurrence of atrial tachyarrhythmia 1 year after the index ablation
时间窗: 1 year
Comparison of the prevalence of atrial tachyarrhythmia recurrence 1 year after the index ablation between groups
Safety (complications)
时间窗: During procedure
Comparison of the number of procedural complications between groups
次要结局
- Total procedural time(During procedure)
- Fluoroscopy time(During procedure)
- RF ablation time(During procedure)
研究者
Sebastien Knecht
Professor Doctor
AZ Sint-Jan AV