NCT03242642招募中不适用
Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO Trial
Medtronic Cardiovascular131 个研究点 分布在 2 个国家目标入组 1,056 人开始时间: 2017年10月23日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,056
- 试验地点
- 131
- 主要终点
- Primary Cohort
研究概览
简要总结
Multi-center, global, prospective, non-randomized, interventional, pre-market trial. All subjects enrolled with receive the study device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Moderate to severe or severe symptomatic mitral regurgitation
- •Local site multidisciplinary heart team experienced in mitral valve therapies agrees that the subject is unsuitable for treatment with approved transcatheter repair or conventional mitral valve intervention
排除标准
- •prior transcatheter mitral valve procedure with device currently implanted
- •anatomic contraindications
- •prohibitive mitral annular calcification
- •left ventricular ejection fraction <25%
- •need for emergent or urgent surgery
- •hemodynamic instability
研究组 & 干预措施
Mitral Annular Calcification -TMVR
Experimental
Treatment of mitral regurgitation with the Medtronic Transcatheter Mitral Valve Replacement System (TMVR)
干预措施: Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR) (Device)
Primary Cohort- TMVR
Experimental
Treatment of mitral regurgitation with the Medtronic Transcatheter Mitral Valve Replacement System (TMVR)
干预措施: Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR) (Device)
结局指标
主要结局
Primary Cohort
时间窗: 1 year
Composite of all-cause mortality or heart failure hospitalization
MAC Cohort
时间窗: 1 year
All-cause mortality
次要结局
- All-cause mortality, disabling stroke, acute kidney injury, prolonged ventilation, deep wound infection, reoperation or reintervention, and major bleeding(30 days or hospital discharge (whichever is later))
- Degree of mitral regurgitation(6 months)
- Quality of Life Improvement(3 months (KCCQ))
- Change in New York Heart Association Class(30 days)
- Echocardiographic assessments of degree mitral valve regurgitation(1 year)
- Cardiovascular hospitalizations(1 year)
研究者
研究点 (131)
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