Percutaneous MitraClip Device or Surgical Mitral Valve REpair in PAtients With PrImaRy MItral Regurgitation Who Are Candidates for Surgery (REPAIR MR)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 500
- 试验地点
- 148
- 主要终点
- Proportion of subjects with moderate or less MR (≤2+), without mitral valve replacement, and without recurrent mitral valve intervention (surgical or percutaneous)
研究概览
简要总结
The objective of this randomized controlled trial (RCT) is to compare the clinical outcome of MitraClip™ device versus surgical repair in patients with severe primary MR who are at moderate surgical risk and whose mitral valve has been determined to be suitable for correction by MV repair surgery by the cardiac surgeon on the local site heart team.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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 severe (Grade III or greater per the ASE criteria, which includes severity grades of 3+ and 4+) primary MR (mixed etiology is acceptable provided the principal mechanism of action is a degenerative mitral valve) as assessed by the ECL.
- •The cardiac surgeon of the Site Heart Team (consisting of at least one interventionalist, and one cardiac surgeon) has confirmed that the subject is a candidate for mitral valve surgery and the EC have confirmed that the subject's mitral valve anatomy is suitable for percutaneous repair with the MitraClip™ device with high certainty of achieving MR ≤ mild
- •Subject is symptomatic (NYHA Class II/III/IV) or asymptomatic with LVEF ≤ 60%, pulmonary artery systolic pressure > 50 mmHg, or LVESD > 40 mm
- •Subject is at moderate surgical risk defined as being at least 75 years of age at the time of EC review. If younger than 75 years, then the subject should have:
- •Society of Thoracic Surgeons (STS) Predicted Risk of Mortality (PROM) Repair Score ≥ 2%, OR
- •Presence of other comorbidities which may introduce a potential surgery-specific impediment
- •Subject provides written informed consent
- •Subject is ≥ 18 years of age
排除标准
- •Subject is currently participating in another clinical investigation
- •Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.
- •Subject has ischemic or non-ischemic secondary MR
- •Concomitant severe tricuspid valve regurgitation
- •Ejection fraction <30%
- •Severe mitral annular calcification
- •Acute myocardial infarction in the past 12 weeks
- •Need for cardiac surgery to correct pulmonary valve disease, aortic valve disease, or tricuspid valve disease
- •Subjects who have concurrent coronary artery disease that needs to be treated may be included provided the subjects are eligible for both percutaneous coronary intervention (PCI) and coronary artery bypass surgery. Subjects randomized to the device group, must undergo PCI before the MitraClip™ device procedure. Subjects randomized to the surgical (control) arm may undergo coronary artery revascularization during mitral valve repair surgery
- •Surgical procedure performed in the past 30 days
- •Femoral vein cannot accommodate a 24 F catheter or presence of IVC filter would interfere with the catheter or ipsilateral DVT
- •Transesophageal echocardiography (TEE) is contraindicated.
- •Hemodynamic instability: systolic pressure ≤ 90 mmHg without afterload reduction, cardiogenic shock, or the need for inotropic support or IABP
- •Need for emergency surgery for any reason
- •Prior mitral valve surgery, valvuloplasty, mechanical prosthetic valve or VAD
- •Systolic anterior motion of the mitral valve
- •Hypertrophic cardiomyopathy
- •Renal insufficiency requiring dialysis
- •Active infections requiring current antibiotic therapy
研究组 & 干预措施
Control Arm
Mitral Valve Repair Surgery
干预措施: Mitral Valve Repair Surgery (Procedure)
Device Arm
MitraClip™ device implantation
干预措施: MitraClip™ device implantation (Device)
结局指标
主要结局
Proportion of subjects with moderate or less MR (≤2+), without mitral valve replacement, and without recurrent mitral valve intervention (surgical or percutaneous)
时间窗: 2 Years
Proportion of subjects with moderate or less MR (≤2+), without mitral valve replacement, and without recurrent mitral valve intervention (surgical or percutaneous) from the time of index procedure through 2 years in the Device and Control groups, respectively
All-cause mortality, stroke, cardiac hospitalization, or acute kidney injury requiring renal replacement therapy at 2 years (any cardiac hospitalizations in the first 30 days post treatment will be excluded)
时间窗: 2 Years
The proportion of subjects who are alive, without stroke, CV hospitalization or acute kidney injury requiring renal replacement therapy at 2 years in the Device and Control groups, respectively
次要结局
- Number of days at hospital from index procedure to home discharge(At Discharge (≤ 14 days following index procedure))
- Proportion of subjects with MR ≤ mild at 30 days post index procedure among survivors(30 Days)
- Quality of life improvement assessed using the Kansas City Cardiomyopathy Questionnaire (KCCQ) of at least 10 points at 2 years compared to baseline among survivors.(2 Years)
- Proportion of subjects discharged to home post index hospitalization(At Discharge (≤ 14 days following index procedure))
- Severe symptomatic mitral stenosis at 1 year(1 Year)