Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR Transfemoral System in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 74
- 主要终点
- Efficacy: Percentage of subjects with none/trace or mild mitral regurgitation at 30 days post-procedure.
研究概览
简要总结
Evaluate the safety and efficacy of Medtronic Intrepid™ TMVR TF System in patients with moderate-to-severe or severe symptomatic mitral regurgitation, or moderate symptomatic mitral regurgitation combined with mitral stenosis in the presence of MAC who, by agreement of the local site multidisciplinary heart team experienced in mitral valve therapies, are unsuitable for treatment with approved transcatheter repair or surgical mitral valve intervention.
详细描述
Prospective, single-arm, multi-center, interventional, pre-market trial
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
- •Subject has moderate-to-severe or severe symptomatic mitral regurgitation as defined by the American Society of Echocardiography 2017 Guidelines and Standards - Recommendations for Non-invasive Evaluation of Native Valvular Regurgitation, or subject has moderate symptomatic mitral regurgitation combined with mitral stenosis with the presence of MAC
- •Local site multidisciplinary heart team experienced in mitral valve therapies agrees that patient is unsuitable for treatment with approved transcatheter repair or conventional mitral valve surgery
- •Subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits
- •Subject meets the legal minimum age to provide informed consent based on local regulatory requirements
- •Subjects anatomically suitable for the Medtronic Intrepid™ TMVR TF System
排除标准
- •Estimated life expectancy of less than 24 months
- •Currently surgically implanted mitral valve
- •Prior transcatheter mitral valve procedure with device currently implanted
- •Anatomic contraindications
- •Anatomically prohibitive mitral annular calcification (MAC)
- •Aortic valve disease requiring intervention or previous intervention within 90 days of enrollment
- •LVEF < 25% (measured by resting transthoracic echocardiogram), patients with LVEF 25 - <30% will be further evaluated by the Screening Committee for approval (Right Ventricular Dysfunction, pulmonary hypertension, and left ventricular function)
- •Left ventricular end diastolic diameter (LVEDD) > 75mm
- •Need for emergent or urgent surgery
- •Hemodynamic instability
- •History of bleeding diathesis or coagulopathy
- •End stage renal disease
- •Liver failure
研究组 & 干预措施
Medtronic Intrepid™ TMVR TF System
Medtronic Intrepid™ TMVR TF System
干预措施: Medtronic Intrepid™ TMVR TF System (Device)
结局指标
主要结局
Efficacy: Percentage of subjects with none/trace or mild mitral regurgitation at 30 days post-procedure.
时间窗: 30 days
Percentage of subjects with none/trace or mild mitral regurgitation at 30 days post-procedure as assessed by the Echocardiography Core Laboratory.
Safety: all-cause mortality at 1-year post-procedure.
时间窗: 1 year
Rate of all-cause mortality at 1-year post-procedure.
次要结局
- Quality of Life (QoL) as assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ) (Efficacy).(1 year)
- Rate of all-cause mortality (Safety).(30 days)
- Disabling stroke (Safety).(30 days)
- Acute Kidney Injury (stage 3 or with renal replacement) (Safety).(30 days)
- Major access site vascular complications (Safety).(30 days)
- NYHA functional class (Efficacy).(1 year)
- Reoperation or reintervention (Safety).(30 days)
- Mitral valve regurgitation (Efficacy).(1 year)
- Cardiovascular hospitalizations (Efficacy).(1 year)