NCT04124328已完成不适用
The MARSHALINE Study: Evaluation of Vein of Marshall Ethanol Infusion During Left Atrial Linear Ablation in Patients With Persistent Atrial Fibrillation
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Procedural succes rate
研究概览
简要总结
In this prospective, randomized, controlled, unblinded, mono-center study, we aim to evaluate the efficacy of vein of Marshall ethanol infusion during left atrial linear ablation in patients with atrial fibrillation compared to the ALINE protocol.
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 between the ages of 18 and 85 years
- •Diagnosed with symptomatic AF without previous mitral isthmus line ablation
排除标准
- •Previous MI line ablation
- •Left atrial thrombus. LAA thrombus can be determined by preprocedural imaging: CT, TEE or MRI.
- •LA diameter greater than 55 mm on long axis parasternal view, or left atrial volume more than 200 cc.
- •Left ventricular ejection fraction <35%.
- •Cardiac surgery within the previous 90 days.
- •Expecting cardiac transplantation or other cardiac surgery within 180 days.
- •Coronary PTCA/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
- •Renal insufficiency
- •Unstable angina.
- •History of blood clotting or bleeding abnormalities.
- •Contraindication to anticoagulation.
- •Life expectancy less than 1 year.
- •Uncontrolled heart failure.
- •Presence of a condition that precludes vascular access.
- •INR 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
ALINE only group
Active Comparator
Patients in this arm are scheduled for an extended AF ablation, including the mitral isthmus line, according to the ALINE criteria
干预措施: ALINE only (Procedure)
VoM group
Active Comparator
Patients in this arm are scheduled for an extended AF ablation, including the mitral isthmus line, according to the ALINE criteria and vein of Marshall (VoM) ethanol infusion
干预措施: ALINE + VoM infusion (Procedure)
结局指标
主要结局
Procedural succes rate
时间窗: At time of ablation
Mitral isthmus block rate after one pass of the mitral line
次要结局
- Changes in quality of life (SF36)(From inclusion to one month post procedure)
- Total procedure time(At time of ablation)
- Fluoroscopy time(At time of ablation)
- Total RF ablation time(At time of ablation)
- Total extent of ablated LA tissue(At time of ablation)
- Cardiovascular-related hospitalizations(From time of ablation to one month post procedure)
- Incidence of atrial flutter(From time of ablation to one month post procedure)
研究者
Sebastien Knecht
Professor Doctor
AZ Sint-Jan AV
研究点 (1)
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