Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO Trial

Medtronic Cardiovascular128 个研究点分布在 3 个国家目标入组 1,056 人2017年10月23日

适应症Mitral Valve Regurgitation

干预措施Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR)

概览

阶段: 不适用
干预措施: Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR)
疾病 / 适应症: Mitral Valve Regurgitation
发起方: Medtronic Cardiovascular
入组人数: 1056
试验地点: 128
主要终点: Primary Cohort
状态: 招募中
最后更新: 上个月

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

概览

简要总结

Multi-center, global, prospective, non-randomized, interventional, pre-market trial. All subjects enrolled with receive the study device.

注册库

clinicaltrials.gov

开始日期

2017年10月23日

结束日期

2036年9月30日

最后更新

上个月

研究类型

Interventional

研究设计

Single Group

性别

All

研究者

发起方

Medtronic Cardiovascular

责任方

Sponsor

入排标准

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

Primary Cohort- TMVR

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)

Mitral Annular Calcification -TMVR

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)

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)