Exclusion of the Left Atrial Appendage With the AtriClip LAA Exclusion Device in Patients Undergoing Concomitant Cardiac Surgery
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 14
- 主要终点
- Rate of Device Related Serious Adverse Events
研究概览
简要总结
Prospective, non-randomized trial to evaluate the safety and efficacy of the LAA Exclusion Device (Clip) for the exclusion of the LAA via epicardial tissue approximation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Subject is greater than or equal to 18 years of age.
- •Subject has any one of the following risk factors and is thought to benefit from LAA occlusion:
- •CHADS score > 2
- •Age > 75 years
- •Hypertension and age > 65 years
- •Previous stroke
- •History of atrial fibrillation (any classification)
- •Subject is scheduled to undergo elective non-endoscopic cardiac surgical procedure(s) including cardiac surgery for one or more of the following: Mitral valve repair or replacement, Aortic valve repair or placement, Tricuspid valve repair or replacement, Coronary artery bypass procedures, concomitant surgical (ablation or cut-and-sew) Maze procedure, patent foramen ovale (PFO), atrial septal defect (ASD) repair with the device deployed while on or prepared for cardio-pulmonary bypass support.
- •Subject is willing and able to provide written informed consent.
- •Subject has a life expectancy of at least 1 year.
- •Subject is willing and able to return for scheduled follow-up visits.
排除标准
- •Previous cardiac surgery
- •Thrombus in the LAA/LA which cannot be evacuated prior to placement of the Clip.
- •Patients requiring surgery other than CABG and/or cardiac valve and/or surgical maze procedure and/or PFO closure and/or ASD repair.
- •NYHA Class IV heart failure symptoms
- •Need for emergent cardiac surgery (i.e. cardiogenic shock)
- •Creatinine >200 µmol/L
- •LAA is not appropriate for exclusion based on intraoperative evaluations
- •Current diagnosis of active systemic infection
- •Renal failure requiring dialysis or hepatic failure
- •A known drug and/or alcohol addiction
- •Mental impairment or other conditions which may not allow the subject to understand the nature, significance and scope of the study
- •Pregnancy or desire to get pregnant within 12-months of the study treatment
- •Preoperative need for an intra-aortic balloon pump or intravenous inotropes
- •Patients who have been treated with thoracic radiation
- •Patients in current chemotherapy
- •Patients on long term treatment with steroids not including intermittent use of inhaled steroids for respiratory diseases.
- •Patients with known connective tissue disorders
结局指标
主要结局
Rate of Device Related Serious Adverse Events
时间窗: Discharge/30 days Post Procedure
The primary safety endpoint is the rate of device related serious adverse events within 30 days post-procedure or hospital discharge, whichever is later, compared with the rates for serious adverse events for LAA exclusion reported in the peer review literature. The safety endpoint was determined based on an independent review of all reported adverse events by an independent cardiac surgeon that was not an investigator in the study.
Percent of Patients With Complete Occlusion of the Left Atrial Appendage.
时间窗: 3 Months Post Procedure
The primary efficacy endpoint is defined as the complete exclusion of the LAA defined by lack of fluid communication between the LA and LAA at both intra-operative (TEE) and 3 month (CT) evaluations and intra-operative verification of completeness of LAA exclusion.
次要结局
未报告次要终点