Early Feasibility Study of the Neovasc Tiara™ Mitral Transcatheter Heart Valve With the Tiara™ Transapical Delivery System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 19
- 主要终点
- Freedom From All-cause Mortality and Major Adverse Events
研究概览
简要总结
The purpose of this study is to evaluate the safety and initial performance of the Neovasc Tiara Mitral Transcatheter Heart Valve with the Tiara Transapical Delivery System.
详细描述
This is an international, multicenter, single arm, prospective, Early Feasibility Clinical Study to evaluate the safety and performance of the Neovasc Tiara Mitral Valve System in subjects with symptomatic severe mitral regurgitation requiring mitral valve replacement who are at high risk for open chest surgery.
A maximum of 30 subjects will be implanted in this study at a maximum of 10 sites. A maximum of 15 subjects will be implanted in the United States.
Subjects satisfying the inclusion criteria and exclusion criteria will be enrolled to receive the Neovasc Tiara Mitral Transcatheter Heart Valve with the Tiara Delivery System via a transcatheter mitral valve replacement (TMVR) 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
- •Severe symptomatic mitral regurgitation (Stage D)
- •High surgical risk for open mitral valve surgery
- •Subject meets the anatomical eligibility criteria for available size(s)
- •NYHA Class III or IV heart failure
排除标准
- •DMR deemed by the heart team to be operable.
- •Prohibitive risk, deemed too frail or listed for cardiac transplant.
- •Unsuitable cardiac structure
研究组 & 干预措施
Treatment
Transcatheter mitral valve replacement with the TIARA valve and transapical delivery system
干预措施: Mitral valve replacement (Device)
结局指标
主要结局
Freedom From All-cause Mortality and Major Adverse Events
时间窗: From the time of implant procedure to 30 days or hospital discharge (whichever is later)
Defined as disabling stroke, myocardial infarction, renal failure requiring dialysis, life-threatening bleeding, and cardiac surgical or transcatheter reintervention
Freedom From All-cause Mortality and Major Adverse Events
时间窗: From the time of implant procedure to 30 days or hospital discharge up to 45 days (whichever is later)
Defined as disabling stroke, myocardial infarction, renal failure requiring dialysis, life-threatening bleeding, and cardiac surgical or transcatheter reintervention
次要结局
- Number and Percentage of Subjects With Progression of Heart Failure(One year)
- Performance(30 days, 90 days, 180 days and annually for five years)
- Individual 30 Day Rates of Device and Procedure Related Major Adverse Events(30 days)
- Device Success; Delivery and Deployment of the Device in the Correct Position and Retrieval of Delivery Catheter(Post procedure, discharge, 30 days, 90 days, 180 days and annually for five years)
- Number and Percentage of Subjects With All-cause Mortality, Disabling Stroke, Myocardial Infarction, Renal Failure Requiring Dialysis, Life-threatening Bleeding and Cardiac Surgical or Transcatheter Reintervention(30 days, 90 days, 180 days and annually to five years)
- Days Alive and Out of Hospital(At one year)
- Individual 30 Day Rates of Device and/or Procedure Related Major Adverse Events(30 days)
- Device Success; Delivery and Deployment of the Device in the Correct Position and Retrieval of Delivery Catheter(Post procedure)
- Performance - KCCQ(30 days, 90 days, 180 days and annually for five years)
- Performance - NYHA(30 days, 90 days, 180 days and annually for five years)
- Performance - 6MWT(30 days, 90 days, 180 days and annually for five years)