A Feasibility Study of the Mitralign Annuloplasty System for the Treatment of Chronic Functional Mitral Valve Regurgitation
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 13
- 主要终点
- Major Adverse Events (MAE)
研究概览
简要总结
The purpose of this study is to test the safety and device performance of the Mitralign system ("MPAS") to treat functional mitral valve regurgitation.
详细描述
The ALIGN study is a single arm, prospective study. The objective of the study is to investigate the safety and performance of a catheter-based plication device intended to reduce the circumference of the dilated mitral valve. The study will enroll up to 50 subjects from up to 5 sites (Paraguay, Columbia, Dominican Republic, Brazil, and India) who will be followed for 36 months post index procedure. Enrollment is defined at the time the study device is inserted into the body and patients will be followed at 30 days, and Months 6, 12, 24 and 36 post index procedure.
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
- •NYHA II-IV
- •Structurally normal mitral valve
- •At least Grade 2 mitral regurgitation
- •Left ventricular ejection fraction not less than 20% and not greater than 45%
- •Left ventricular end diastolic diameter not less than 5.0 cm and not greater than 7.5 cm
排除标准
- •Pregnant or lactating female
- •Mitral stenosis
- •Mod/severe aortic stenosis or regurgitation
- •Mod/severe tricuspid stenosis or regurgitation
- •Endocarditis
- •Previous mitral valve repair or MV replacement
- •Bioprosthetic or mechanical aortic valve
- •Known unstable angina or MI within 30 days prior to procedure
- •CVA within past 6 months
- •Known contraindications to blood transfusion, contrast dye, DAPT
结局指标
主要结局
Major Adverse Events (MAE)
时间窗: within 30 days post procedure
MAE defined as occurrence of any of the following: Mitral valve-related surgery/intervention, myocardial infarction, cardiac tamponade, stroke, device and/or procedure-related death
次要结局
- Echocardiographic Outcomes(at 6 months)