Left Atrial Appendage Closure Registry of Henri Mondor Hospital
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Frequency of thrombo-embolic events
研究概览
简要总结
Intro: Patients with atrial fibrillation are at significant risk of thrombus formation in the left atrial appendage, which can lead to strokes or systemic embolisms. This risk justifies first-line prescribing of long-term oral anticoagulant therapy in these patients. Percutaneous left atrial appendage closure, is an interventional cardiology technique for patients at high risk of stroke related to atrial fibrillation in whom long term anticoagulation therapy cannot be conducted. This procedure involves implantation of an occlusion device into the left atrial appendage to close it and prevent migration of thrombotic material that could otherwise cause distant embolism. Closure of the left atrial appendage avoids long-term prescription of anticoagulants while protecting patients against the risk of systemic embolism and stroke.
Hypothesis/Objective: the main objective of this study is to assess the long term efficacy of left atrial closure, 5 years after the procedure Method: 150 patients will be included prospectively. We will also include restropectively100 other patients, previously treated by left atrial appendage closure at Henri Mondor hospital. Demographic, clinical, echocardiographic, and computed tomography data will be obtained by physical examination or medical records.
Conclusion: this study will allow to assess the long term efficacy of left atrial closure in atrial fibrillation patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Any patient for whom an indication has been made for implantation of a device for the closure of the left atrial appendage without restriction of indication and regardless of the outcome of the procedure (implantation success or not)
排除标准
- •Refusal of the patient to participate in this study
- •Minor patient
- •Patient not affiliated to the French social security system
结局指标
主要结局
Frequency of thrombo-embolic events
时间窗: 60months of follow-up after the procedure
The primary efficacy endpoint is the frequency of a combined endpoint including ischemic strokes and systemic embolisms after left atrial appendage closure. This frequency will be expressed as the percentage of patients who presented at least one of these events. Only the first event occurring in each patient will be taken into account, in the case where the same patient would present several events.
次要结局
- Percentage of transient ischemic attack (TIA)(1 and 5 years after the procedure)
- Percentage of device thrombosis(3 months; 1 year; 5 year)
- Percentage of ischemic stroke(1 and 5 years after the procedure)
- Comparison of the rate of thromboembolic events to expected values(1 and 5 years after the procedure)
- Bleedings not-related to the procedure or the device(1 year; 5 year)
- Occlusion of the left atrial appendage(3 months)
- Percentage of systemic embolism(1 and 5 years after the procedure)
- Bleeding (all cause)(1 year; 5 year)
- residual peri-device leak(3 months)
- All-cause mortality(1 and 5 years after the procedure)
- Percentage of migration of the device(3 months; 1 year; 5 years)
- Criteria for Evaluating Associated Antithrombotic Treatments(: Discharge, 3, 6, 12 months after the procedure, 1 and 5 years after the procedure)
- Description of the population(At inclusion)
- Efficacy of the procedure(One hour after the end of the procedure)
- Cardiovascular or unexplained death(1 and 5 years after the procedure)
- Rate of complications related or potentially related to the device or the implantation procedure(periprocedural period (defined as the time from the day of the procedure to day 7 or discharge, whichever comes last))
- Percentage of pericardial effusion(3 months)
- Percentage of pericardial effusion(Periprocedural period (defined as the time from the day of the procedure to day 7 or discharge, whichever comes last))
- Percentage of migration of the device(periprocedural period (defined as the time from the day of the procedure to day 7 or discharge, whichever comes last))