An Initial Evaluation of the Safety and Performance of the Transcatheter Mitral Intrepid Valve Replacement System in Patients With Severe, Symptomatic Mitral Regurgitation
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 128
- 试验地点
- 48
- 主要终点
- Percent of Subjects With Adverse Events
研究概览
简要总结
PILOT:
The study is a pilot trial to evaluate the safety and performance of the Twelve TMVR System in high risk mitral regurgitation patients.
EFS:
The study is an Early Feasibility Study to evaluate the safety and performance of the Medtronic Intrepid™ Transcatheter Mitral Valve Replacement System with Transfemoral Transseptal access in Patients with moderate-Severe or severe, Symptomatic Mitral Regurgitation
详细描述
PILOT:
The study is a prospective, multi-center, non-randomized study to evaluate the safety and performance of The Intrepid™ TMVR System in patients with severe, symptomatic mitral regurgitation, who are at high risk for conventional mitral valve surgery.
EFS:
The study is a multi-center, prospective, non-randomized, trial to evaluate the safety and performance of the Medtronic Intrepid™ Transcatheter Mitral Valve Replacement System with Transfemoral Transseptal access in Patients with Moderate-Severe or Severe, Symptomatic Mitral Regurgitation
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 mitral regurgitation (PILOT)
- •moderate-severe or severe mitral regurgitation (EFS)
- •Symptomatic mitral regurgitation (NYHA Class II-IV)
- •Deemed to be at high risk for conventional mitral valve surgery by the local heart team (including, at minimum, a cardiac surgeon, interventional cardiologist, and an echocardiologist) (PILOT and EFS)
- •Subjects anatomically suitable for the Intrepid TMVR delivery system, including transfemoral and transseptal access (EFS only)
- •Native mitral valve geometry and size compatible with the Intrepid™ TMVR (PILOT)
排除标准
- •Left ventricular ejection fraction (LVEF) < 20 (PILOT) or <30% (EFS)
- •Evidence of intracardiac mass, thrombus, or vegetation
- •Prior valve surgery or need for other valve surgery
- •Prior stroke within 30 days (PILOT) or 90 days (EFS)
- •Gastrointestinal bleeding within 6 months (PILOT)
- •Prior myocardial infarction 90 days (EFS)
- •Need for coronary revascularization
- •History of, or active, endocarditis if antibiotics are required (EFS)
- •Renal insufficiency; Serum Creatinine > 2.5 mg/dL (PILOT) or Creatinine Clearance <30 cc/min (EFS)
研究组 & 干预措施
Transcatheter Mitral Valve Replacement (TMVR) Implant
Twelve TMVR Implant
干预措施: Twelve TMVR Implant (Device)
Transcatheter Mitral Valve Replacement (TMVR) Implant
Twelve TMVR Implant
干预措施: Medtronic Intrepid™ Transcatheter Transfemoral Mitral Valve Replacement System (Device)
结局指标
主要结局
Percent of Subjects With Adverse Events
时间窗: 30 days
PILOT: Site Reported Serious Adverse Events Implant or Delivery Related Through 30-Days EFS: Implant, Delivery or device related serious adverse events through 30 days post procedure
次要结局
- Change in Mitral Regurgitation (MR) From Baseline Through 30 Days(Through 30 Days)
- Percent of Subject With Left Ventricular Outflow Tract (LVOT) Patency(30 Days post procedure)
- Number of Subject With Left Ventricle Output Tract (LVOT) Patency(Through 30 days)
- Number of Subjects With Procedural Success(Procedure)
- Change in New York Heart Association (NYHA) From Baseline Through 30 Days(Through 30 Days)
- Number of Subjects Without Mitral Valve Stenosis(Through 30 days)
- Number of Subjects With Greater Than or Equal Moderate (2+) Mitral Regurgitation at 30-days(Through 30 days)
- Change in Mitral Regurgitation (MR) From Baseline Through 30 Days(30 days)
- Change in New York Heart Association (NYHA) From Baseline Through 30 Days(Through 30 days)