Pivotal Study: A Study of the Evalve Cardiovascular Valve Repair System - Endovascular Valve Edge-to-Edge REpair STudy (EVERESTIIRCT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 279
- 试验地点
- 2
- 主要终点
- Number of Participants With Major Adverse Events (MAE)
研究概览
简要总结
EVEREST II Randomized Controlled Trial (RCT) is a prospective, multi-center, randomized study of the MitraClip® System in the treatment of mitral valve regurgitation, randomizing patients to MitraClip or mitral valve surgery. The EVEREST II High Risk Registry (HRR) study is a prospective multi-center study of the MitraClip System for the treatment of mitral valve regurgitation in high surgical risk patients. Enrollment in the RCT and HRR is closed. A continued access prospective, multi-center study (REALISM) of the MitraClip System in a surgical population (non-high risk arm) and a high surgical risk population (high risk arm) is ongoing. Enrollment in the non-high risk arm of REALISM is closed. Enrollment in the high risk arm of REALISM is ongoing. Patients enrolled in EVEREST II undergo 30-day, 6-month, 12-month, 18-month and 24-month clinical and echocardiographic follow-up, and then annually for 5 years.
详细描述
Prospective, multi-center, randomized study of the safety and effectiveness of an endovascular approach to the treatment of mitral valve regurgitation using the Evalve Cardiovascular Valve Repair System (MitraClip® implant).
A minimum of 279 evaluable patients randomized 2:1 to MitraClip or mitral valve surgery, respectively, are required to test the primary safety and effectiveness endpoints of the RCT. Enrollment in the RCT is now complete. 60 roll-in patients were enrolled under EVEREST II RCT.
38 clinical sites throughout the US and Canada have participated in the RCT and HRR. 37 US sites are participating in REALISM.
The RCT is powered to test the hypothesis MitraClip has both superiority of safety and non-inferiority of effectiveness compared to mitral valve repair or replacement surgery. The HRR is powered to show lower mortality at 30 days with the MitraClip than predicted surgical mortality.
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
- 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
- 未提供
排除标准
- •Patients with Grade 3 (moderate to severe) or Grade 4 (severe) mitral regurgitation (MR) based on American Society of Echocardiography guidelines:
- •Are 18 years or older.
- •Symptomatic
- •If asymptomatic, must have new onset of atrial fibrillation, pulmonary hypertension, or evidence of left ventricular dysfunction
- •Are candidates for mitral valve surgery
- •Are candidates for transseptal catheterization
- •Primary regurgitant jet must originate from malcoaptation of the A2 and P2 scallops of the mitral valve
- •Appropriate valve anatomy for MitraClip
- •Does not need other cardiac surgery or any emergency surgery
- •Did not experience myocardial infarction in prior 12 weeks or endovascular procedure in prior 30 days
- •Mitral valve orifice area ≥ 4 cm2
- •Do not have renal insufficiency
- •Echocardiographic evidence of intracardiac mass, thrombus or vegetation
研究组 & 干预措施
1
Percutaneous mitral valve repair using MitraClip implant. The calculated sample size was 186 patients in the device arm
干预措施: Percutaneous mitral valve repair using MitraClip implant (Device)
2
Mitral valve repair or replacement surgery. The calculated sample size was 93 patients in the control arm.
干预措施: Mitral valve repair or replacement surgery (Procedure)
结局指标
主要结局
Number of Participants With Major Adverse Events (MAE)
时间窗: 30 days
Defined as a combined clinical endpoint of death, myocardial infarction, reoperation for failed surgical repair or replacement, nonelective cardiovascular surgery for adverse events, stroke, renal failure, deep wound infection, ventilation for greater than 48 hours, gastrointestinal (GI) complication requiring surgery, new onset of permanent atrial fibrillation, septicemia, and transfusion of 2 or more units of blood.
Number of Participants With Freedom From Surgery for Valve Dysfunction, Death, and Moderate to Severe (3+) or Severe (4+) Mitral Regurgitation (MR).
时间窗: 12 months
次要结局
- Cardiac Index (CI)(12 months)
- Number of Participants With Clip Implant Rate(Day 0)
- Number of Participants With Acute Procedural Success(30 Days)
- Number of Participants With MAE: Surgery After Device and First Time Surgery Control(30 days)
- Number of Participants With Major Adverse Events (MAE)(12 months.)
- Number of Participants With Dysrhythmia(12 months)
- Number of Participants With Thrombosis.(12 months)
- Number of Participants With Clinically Significant Atrial Septal Defect (ASD)(12 months)
- Mitral Valve Area by Planimetry Index(24 months)
- Number of Participants With Major Vascular Complications(12 months)
- Number of Participants With Major Bleeding Complications.(12 months)
- Number of Participants With Incidence of Hospital Readmissions for Congestive Heart Failure (CHF).(30 days)
- Number of Participants With Hemolysis(12 months)
- Number of Participants With Clinically Significant Atrial Septal Defect (ASD).(30 days)
- Mitral Valve Area by Pressure Half-time Index(24 months)
- Post-procedure Length of Hospital Stay(30 Days)
- Post-procedure Intensive Care Unit (ICU) / Critical Care Unit (CCU) Duration(30 Days)
- Number of Participants With Incidence of Discharge to a Nursing Home or Skilled Nursing Facility/Hospital(30 Days)
- Number of Participants With Durability of the MitraClip Device and Surgery.(24 months-3 year)
- Number of Participants With Freedom From Death and Mitral Valve Surgery/Re-operation(5 years)
- Number of Participants With Non-cerebral Thromboembolism.(30 days)
- Mitral Valve Area by Pressure Half-time(5 years)
- Number of Participants With Mitral Valve Stenosis(5 years)
- Mitral Valve Area by Planimetry(5 years)
- Number of Participants With New Coumadin (Warfarin) Usage(12 months)
- Number of Participants With Freedom From Death, Mitral Valve Surgery/Re-operation and MR > 2+(3 years)
- Transvalvular Mitral Valve Gradient(At Discharge (≤ 14 days following index procedure))
- Transvalvular Mitral Mean Pressure Gradient (Mean MVG)(5 years)
- Number of Participants With Hospital Re-admissions(30 days)
- Number of Participants With Freedom From Mitral Valve Surgery/Re-operation(5 years)
- Number of Participants With Incidence of Mitral Valve Replacement(24 months)
- Freedom From All-Cause Mortality(5 years)
- Number of Participants With Freedom From Surgery for Valve Dysfunction, Death, and Moderate to Severe (3+) or Severe (4+) Mitral Regurgitation (MR) in Intention to Treat Strategy Cohort(24 months)
- Left Ventricular Ejection Fraction (LVEF)(5 years)
- Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease.(5 years)
- Number of Participants With MitraClip Device Embolization/Single Leaflet Device Attachment(12 months to 5 years)
- Number of Participants With MR Severity(5 years)
- Left Ventricular Status- Left Ventricular End-diastolic Volume (LVEDV), Left Ventricular End-systolic Volume (LVESV)(30 days)
- Left Ventricular Status- LVEDV, LVESV(5 years)
- Left Ventricular Internal Dimension Systole (LVIDs)(5 years)
- Left Ventricular Internal Dimension Diastole (LVIDd)(5 years)
- Percentage of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease: NYHA Functional Class III or IV(5 years)
- Number of Participants With Procedural Freedom From In-hospital MAE.(Day 0)
- Cardiac Index(24 months)
- Regurgitant Volume(24 months)
- Number of Participants With Acute Surgical Success(30 Days)
- Number of Participants With Freedom From Surgery for Valve Dysfunction, Death, and Moderate to Severe (3+) or Severe (4+) Mitral Regurgitation.(12 months)
- Number of Participants With Freedom From Surgery for Valve Dysfunction, Death, and Moderate to Severe (3+) or Severe (4+) Mitral Regurgitation (MR).(24 months)
- New York Heart Association (NYHA) Functional Class Cardiac Disease: NYHA Functional Class III or IV(30 days)
- Short Form (SF)-36 Quality of Life Questionnaire.(12 months)
- Cardiac Output(24 months)
- Regurgitant Fraction (RF)(30 Days)
- Regurgitant Fraction(24 months)
- Number of Participants With Successful Clip Implant and Acute Procedural Success(30 days)
- Number of Participants With Mitral Valve Repair Success.(24 months)
- Number of Participants With Procedural Freedom From In-hospital MAE(Day 30)
- Number of Participants With MAE in Patients Over 75 Years of Age.(12 months)
- Number of Participants With Endocarditis.(12 months)