HRT Observational Study of a Mitral Bridge in Patients With Moderate to Severe Mitral Valve Regurgitation to Evaluate Device Safety and Performance
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Clinical Success
研究概览
简要总结
Prospective, observational, multi-center trial in which patients with mitral regurgitation sufficient to merit mitral valve repair will receive a surgical transvalvular, intra-annular Mitral Bridge™ to reduce or eliminate mitral regurgitation.
详细描述
The primary objective of this study is to evaluate the safety and performance of the Mitral Bridge device in the correction of mitral valve regurgitation in patients who qualify for mitral valve repair as defined by the American Society of Echocardiography (ASE). The device is a single use, mitral valve implant designed to reduce mitral regurgitation by reducing the septo-lateral mitral annular diameter, promoting early coaptation of the valve leaflets and restraining the leaflets below the intra-annular plane.
The protocol was designed as a First In Man (FIM) with a 6-month follow up but was amended to follow the enrolled patients for a total of 5 years.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients moderate to severe, symptomatic functional (ischemic or dilated cardiomyopathies) mitral regurgitation or mitral regurgitation caused by dilation of the mitral annulus who qualify for mitral valve repair with cardiopulmonary bypass
- •Mitral regurgitation must meet the following criteria:
- •The primary regurgitant jet is central, originating from mal coaptation of anterior and posterior leaflets of the mitral valve.
- •If a secondary jet is present, the jet must be considered clinically insignificant.
- •Women of child-bearing potential have a negative pregnancy test
排除标准
- •Evidence of severe mitral annular and leaflet calcification.
- •Patient is hemodynamically unstable.
- •Patient has hypertrophic cardiomyopathy and has systolic anterior motion of the leaflets.
- •Patient requires emergency surgery.
- •Patient has echocardiographic evidence of endocarditis or rheumatic heart disease.
- •Transesophageal Echocardiogram (TEE) is contraindicated or cannot be performed intraoperatively for any reason.
- •Patient has known chronic, dialysis-dependent renal failure.
- •History of stroke, transient ischemic attack (TIA) or reversible ischemic neurological disease within the last three (3) months.
- •History of gastrointestinal bleeding within the last three (3) months.
- •History of hypersensitivity or allergy to aspirin
- •History or hypersensitivity to clopidogrel (Plavix) or its congeners.
- •Active or treated malignancies in the last twelve (12) months.
- •Patient is participating in another clinical study for which follow-up is currently ongoing.
- •Women of child-bearing age who have not had a negative pregnancy test.
- •Patient with non-cardiac co-morbidities and life expectancy < 1 year.
- •Patient has a condition that, in the opinion of the Investigator, precludes participation, including willingness to comply with all follow-up procedures.
结局指标
主要结局
Clinical Success
时间窗: One, 3, 6,12, 24, 36, 48, and 60 months
- Freedom from subsequent open mitral valve repair or replacement
次要结局
- Preservation or improvement of left ventricular remodeling(One, 3, 6,12, 24, 36, 48, and 60 months)
- Preservation of improvement in NYHA (New York Heart Association) functional class.(One, 3, 6,12, 24, 36, 48, and 60 months)