A Study to Evaluate the Feasibility and Safety of Mitral Annular Repair With the CathHELIX™ Transcatheter System in Subjects With Functional Mitral Regurgitation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Technical Device Success (measured at the exit of the catheterization laboratory) is defined per Mitral Valve Academic Research Consortium (MVARC).
研究概览
简要总结
Patients with functional mitral regurgitation classified as moderate to severe (3+) or severe (4+) that are symptomatic (NYHA Class II-IV) will be evaluated for treatment using the CathHELIX Transcatheter Mitral Annuloplasty System.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 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
- •Moderate to severe (3+) or severe (4+) functional mitral regurgitation
- •Left ventricular ejection fraction ≥30%
- •Symptomatic New York Heart Association (NYHA) Class II to IV).
排除标准
- •Oxygen dependent for COPD
- •Active or suspected endocarditis
- •Severe symptomatic carotid stenosis
- •Has undergone heart transplantation.
- •Severe calcification of the mitral annulus or leaflets
- •Coronary sinus anatomy that may preclude proper treatment with the device
结局指标
主要结局
Technical Device Success (measured at the exit of the catheterization laboratory) is defined per Mitral Valve Academic Research Consortium (MVARC).
时间窗: Periprocedural
Technical Device Success: MVARC Technical Success is a definition from the Mitral Valve Academic Research Consortium for evaluating transcatheter mitral valve interventions, defined at the exit from the procedure room and requires all of the following conditions to be met: 1. The patient is alive. 2. There was successful access, delivery, and retrieval of the device delivery system. 3. The first intended device was successfully deployed and correctly positioned. 4. There was freedom from emergency surgery or reintervention related to the device or access procedure.
次要结局
未报告次要终点