exClusion of the Left atrIal Appendage With PendITure™ (CLIP-IT) Post-Market Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 198
- 试验地点
- 30
- 主要终点
- Rate of successful exclusion of the left atrial appendage (LAA) from the heart
研究概览
简要总结
The purpose of this study is to collect post-market clinical evidence on performance and clinical outcomes of the Penditure™ Left Atrial Appendage (LAA) Exclusion System in subjects undergoing concomitant cardiac surgery.
详细描述
Multi center, single-arm, nonrandomized, interventional, unblinded, post-market study. Up to 150 subjects will be enrolled and implanted with the Penditure™ Left Atrial Appendage (LAA) Exclusion Clip at up to 25 sites in the United States.
Subjects will be followed at 30 days, 3 months, 12-months and annually for 36-months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Patient is indicated to be treated with the Penditure™ left atrial appendage (LAA) Exclusion System
- •Greater than or equal to 18 years of age
- •The subject is willing and able to provide written informed consent and comply with study visit requirements
排除标准
- •Prior left atrial appendage (LAA) isolation attempt(s)
- •Need for emergent cardiac surgery
- •Subject is contraindicated for multi-detector computed tomography (MDCT) and/or transesophageal echocardiogram (TEE)
- •Life expectancy of less than 12 months
- •History of cardiac surgery
- •Pericarditis
- •Presence of thrombus in the left atrium or left atrial appendage (LAA), prior to or during the procedure
- •Patients requiring a heart transplant, insertion of a ventricular assist device or total artificial heart, and/or ascending aortic aneurysm or dissection repair requiring circulatory arrest
- •Society of Thoracic Surgeons Predicted Risk of Mortality (STS-PROM) score greater than 4 or subject deemed to be high or extreme risk per surgeon assessment
- •Ejection fraction less than 30%
- •Chronic Kidney Disease Stage IV or V (estimated glomerular filtration rate (eGFR) <30 ml/min)
- •New York Heart Association (NYHA) Class IV heart failure symptoms
- •Patient has a documented history of substance (drug or alcohol) abuse
- •Known allergy to device components (Nickel and/or Titanium)
- •In the opinion of the investigator, the subject is not a suitable candidate for LAA isolation due to risks outweighing potential benefits including, complexity of planned concomitant procedures, or other pre-existing medical conditions
- •Currently participating in an investigational drug or another device trial or study (excluding registries)
研究组 & 干预措施
Penditure™ Left Atrial Appendage (LAA) Exclusion System
Penditure™ Left Atrial Appendage (LAA) Exclusion System
干预措施: Penditure™ Left Atrial Appendage (LAA) Exclusion System (Device)
结局指标
主要结局
Rate of successful exclusion of the left atrial appendage (LAA) from the heart
时间窗: 3 months post procedure
The primary efficacy endpoint is the rate of successful exclusion of the left atrial appendage (LAA) from the heart defined as the absence of residual communication (≤ 3 mm residual contrast communication) between the left atrium (LA) and the left atrial appendage (LAA). For those successfully placed devices, exclusion will be confirmed at 3 months as demonstrated by multi-detector computed tomography (MDCT) scan.
Rate of device related adverse events
时间窗: 30 days post procedure
The primary safety endpoint is the composite rate of device-related serious adverse cardiac events at 30-days post-procedure.
Rate of successful exclusion of the left atrial appendage (LAA) from the heart
时间窗: 3 months post procedure
The primary efficacy endpoint is the rate of successful exclusion of the left atrial appendage (LAA) from the heart defined as the absence of residual communication (≤ 3 mm residual contrast communication) between the left atrium (LA) and the left atrial appendage (LAA). For those successfully placed devices, exclusion will be confirmed at 3 months as demonstrated by multi-detector computed tomography (MDCT) scan.
Rate of device related adverse events
时间窗: 30 days post procedure
The primary safety endpoint is the composite rate of device-related serious adverse cardiac events at 30-days post-procedure.
次要结局
- Rate of successful placement of the Penditure™ left atrial appendage (LAA) Exclusion System(At the time of procedure)
- Rate of device related adverse events(At 1 year, 2 year, and 3 years post procedure)
- Rate of successful placement of the Penditure™ left atrial appendage (LAA) Exclusion System(At the time of procedure)
- Rate of device related adverse events(At 1 year, 2 year, and 3 years post procedure)