Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional MR Continued Access Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 162
- 试验地点
- 32
- 主要终点
- Safety end point: Freedom from death
研究概览
简要总结
The COAPT Continued Access Study (CAS) is an extension of the COAPT RCT under the same IDE (G120024). COAPT CAS was a single-arm, prospective, multicenter continued access registry that enrolled heart failure patients with secondary mitral regurgitation who remained symptomatic despite optimal guideline-directed medical therapy (GDMT). The objective of the COAPT CAS is to continue the evaluation of safety and effectiveness of the MitraClip NT System under more "real world" conditions in patients who meet the COAPT inclusion/exclusion criteria and who have national Medicare coverage by the Centers for Medicare and Medicaid Services (CMS).
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
- •Subjects who have national Medicare coverage by CMS
- •Symptomatic functional MR (≥3+) due to cardiomyopathy of either ischemic or non-ischemic etiology
- •Subject has been adequately treated per applicable standards, including for coronary artery disease, left ventricular dysfunction, mitral regurgitation and heart failure
- •Subject has had at least one hospitalization for heart failure in the 12 months prior to subject registration and/or a corrected BNP ≥300 pg/ml or corrected NT-proBNP ≥1500 pg/ml
- •New York Heart Association (NYHA) Functional Class II, III or ambulatory IV
- •Surgery will not be offered as a treatment option and medical therapy is the intended therapy for the subject
- •Left Ventricular Ejection Fraction (LVEF) is ≥20% and ≤50%
- •Left Ventricular End Systolic Dimension (LVESD) is ≤70 mm
排除标准
- •Untreated clinically significant coronary artery disease requiring revascularization
- •Coronary artery bypass grafting (CABG) within prior 30 days
- •Percutaneous coronary intervention within prior 30 days
- •Tricuspid valve disease requiring surgery
- •Aortic valve disease requiring surgery
- •Chronic Obstructive Pulmonary Disease (COPD) requiring continuous home oxygen therapy or chronic outpatient oral steroid use
- •Cerebrovascular accident within prior 30 days
- •Severe symptomatic carotid stenosis (> 70% by ultrasound)
- •Carotid surgery within prior 30 days
- •Mitral valve orifice area < 4.0 cm2
- •Leaflet anatomy which may preclude MitraClip implantation, proper MitraClip positioning on the leaflets or sufficient reduction in MR by the MitraClip
研究组 & 干预措施
The MitraClip NT Device
The MitraClip NT System comprises the MitraClip NT Clip Delivery System
干预措施: MitraClip® NT System (Device)
结局指标
主要结局
Safety end point: Freedom from death
时间窗: through 5 years
Safety end point: Freedom from Myocardial Infarction (MI)
时间窗: through 5 years
Safety end point: Freedom from stroke
时间窗: through 5 years
Safety end point: Heart Failure Hospitalization
时间窗: through 5 years
Recurrent Heart Failure Hospitalization
时间窗: through 5 years
次要结局
未报告次要终点