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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 2
- 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.
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
- 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)
- Changes in quality of life (SF36)(From inclusion to one month post procedure)
研究者
Sebastien Knecht
Professor Doctor
AZ Sint-Jan AV
研究点 (2)
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