A Continued Access Registry of the Evalve® MitraClip® System: EVEREST II Real World Expanded Multicenter Study of the MitraClip System (REALISM)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 965
- 试验地点
- 72
- 主要终点
- Number of Participants With Major Adverse Events
研究概览
简要总结
Prospective, multicenter, continued access registry of the MitraClip® Cardiovascular Valve Repair System in the treatment of mitral valve regurgitation. Patients will undergo 30-day, 6-month, 12-month, 36-month and 60-month clinical follow-up. The study consists of two arms: a High Risk group (NCT01940120) and a Non-High Risk group (NCT00209274) . Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU).
详细描述
The EVEREST II REALISM study (REALISM study) is a continued access registry designed for continued data collection on the use of Abbott Vascular's MitraClip System (MitraClip® Device) under more "real world" conditions. After the completion of enrollment in the pivotal EVEREST II Randomized Controlled Trial (RCT) NCT00209274 and EVEREST II High Risk Registry Study NCT01940120, continued access to the technology was warranted to collect additional safety and effectiveness data on the MitraClip® Device. This continued access study was approved by FDA on November 21, 2008 (G030064). There are two arms (High Risk and Non-High Risk) in the REALISM study. Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). Enrollment in the Non-High Risk arm of the study concluded on April 14, 2011 and enrollment in the High Risk arm concluded on December 19, 2013.
REALISM is a prospective, multi-center, 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). Patients with moderate-to-severe (3+) or severe (4+) mitral regurgitation (MR), as determined by the site from a transthoracic echocardiogram (TTE), were considered for enrollment in this study. The TTE and a transesophageal echocardiogram (TEE) are used to assess eligibility criteria for MR severity, valve anatomy and left ventricular parameters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •The primary regurgitant jet originates from malcoaptation of the A2 and P2 scallops of the mitral valve (MV)
- •Male or non-pregnant female
- •Trans-septal catheterization is determined to be feasible by the treating physician
- •High Risk Arm:
- •Predicted procedural mortality risk calculated using the STS surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a HR surgical candidate due to the presence of one of the following indications:
- •Porcelain aorta or mobile ascending aortic atheroma
- •Post-radiation mediastinum
- •Previous mediastinitis
- •Functional MR with EF <40
- •Over 75 years old with EF<40
- •Re-operation with patent grafts
- •Two or more prior chest surgeries
- •Hepatic cirrhosis
- •Three or more of the following STS high risk factors 9.1 Creatinine >2.5 mg/dL 9.2 Prior chest surgery 9.3 Age over 75 9.4 EF<35
- •Symptomatic moderate to severe (3+) or severe (4+) chronic MR and in the judgment of the investigator intervention to reduce MR is likely to provide symptomatic relief for the patient
- •American Society of Anesthesiologists (ASA) physical status classification of ASA IV or lower
- •Non-High Risk Arm:
- •Moderate to severe (3+) or severe (4+) chronic MV regurgitation and:
- •Symptomatic with >25% LVEF and LVESD ≤55mm or,
- •Asymptomatic with one or more of the following: i. Left Ventricular Ejection Fraction (LVEF) 25% to 60% ii. Left Ventricular End-Systolic Diameter (LVESD) ≥40 mm iii. New onset of Atrial fibrillation (AFib) iv. Pulmonary arterial systolic pressure (PASP) >50 mmHg at rest or >60 mmHg with exercise
- •Candidate for MV repair or replacement surgery, including cardiopulmonary bypass
排除标准
- •Evidence of an Acute Myocardial Infarction (AMI) in the prior 12 weeks of the intended treatment
- •In the judgment of the Investigator, the femoral vein cannot accommodate a 24 French scale (F) catheter or the presence of an inferior vena cava (IVC) filter would interfere with advancement of the catheter or ipsilateral Deep Venous Thrombus (DVT) is present
- •MV orifice area <4.0 cm2
- •If leaflet flail is present:
- •Flail Width ≥15 mm, or
- •Flail Gap ≥10 mm.
- •If leaflet tethering is present:
- •Vertical coaptation length <2 mm
- •Leaflet anatomy which may preclude clip implantation, proper clip positioning on the leaflets or sufficient reduction in MR. This may include:
- •Evidence of calcification in the grasping area of the A2 and/or P2 scallops
- •Presence of a significant cleft of A2 or P2 scallops
- •More than one anatomic criteria dimensionally near the exclusion limits
- •Bileaflet flail or severe bileaflet prolapse
- •Lack of both primary and secondary chordal support
- •Hemodynamic instability (systolic pressure <90 mmHg without afterload reduction or cardiogenic shock or the need for inotropic support or intra-aortic balloon pump).
- •Need for emergency surgery for any reason
- •Prior MV surgery or valvuloplasty or any currently implanted mechanical prosthetic valve or currently implanted Ventricular assist device (VAD)
- •Echocardiographic evidence of intracardiac mass, thrombus or vegetation
- •Active endocarditis or active rheumatic heart disease or leaflets degenerated from either endocarditis or rheumatic disease (i.e. noncompliant, perforated)
- •History of bleeding diathesis or coagulopathy or subject will refuse blood transfusions
- •Life expectancy <12 months
- •Active infections requiring current antibiotic therapy
- •Patients in whom transesophageal echocardiography (TEE) is contraindicated
- •High Risk Arm:
- •EF <20%, and/or LVESD >60 mm
- •Non-High Risk Arm:
- •The need for any other cardiac surgery
- •Any endovascular therapeutic interventional or surgical procedure performed within 30 days prior to the index procedure
- •Severe Left Ventricular (LV) dysfunction (EF <25% and/or LVESD >55mm)
- •Severe mitral annular calcification
- •Systolic anterior motion of the MV leaflet
- •Hypertrophic cardiomyopathy
- •History of a stroke or documented Transient Ischemic Attack (TIA) within the prior 6 months
- •Upper GI bleeding within the prior 6 months
- •Platelet count <75,000 cells/mm³
- •Creatinine >2.5mg/dL
研究组 & 干预措施
Non-High Risk
Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk). The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. This arm was evaluated as a separate study NCT00209274.
干预措施: MitraClip® implant (Device)
High Risk
Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. This arm was evaluated as a separate study NCT01940120.
干预措施: MitraClip® implant (Device)
Compassionate Use
Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
干预措施: MitraClip® implant (Device)
Emergency Use
Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
干预措施: MitraClip® implant (Device)
结局指标
主要结局
Number of Participants With Major Adverse Events
时间窗: 12 months
A combined clinical endpoint of death, myocardial infarction (MI), re-operation for failed surgical repair or replacement, non-elective cardiovascular surgery for adverse events, stroke, renal failure, deep wound infection, ventilation for greater than 48 hours, GI complication requiring surgery, new onset of permanent atrial fibrillation, septicemia and transfusion of 2 or more units of blood.
Number of Participants With 12-Month Efficacy
时间窗: 12 months
Defined as freedom from: Surgery for Mitral Regurgitation (MR) or Valve Dysfunction, death, and MR \> 2+ (moderate to severe (3+) or severe MR (4+)).
次要结局
- Number of Participants With Major Adverse Events in Patients Over 75 Years of Age(5 years)
- Number of Participants With Clinically Significant Atrial Septal Defect (ASD)(12 months)
- Number of Participants With Procedural Success(30 days)
- Number of Participants With Clinical Durability(12 months)
- Device Time(On the day of index procedure)
- Fluoroscopy Duration(On the day of index procedure)
- Number of Participants With Major Adverse Events (MAE) in Patients Over 75 Years of Age(30 days)
- Post-Procedure Intensive Care Unit (ICU)/ Critical Care Unit (CCU)/ Post-anesthesia Care Unit (PACU) Duration(At discharge (an average of ≤ 12.3 days post-index procedure).)
- Post-Procedure Length of Hospital Stay(At discharge (an average of ≤ 12.3 days post-index procedure).)
- Number of Participants With Device Embolization or Single Leaflet Device Attachment (SLDA)(0 to 5 years)
- Number of Participants With Mitral Regurgitation (MR) Severity(30 days(Follow-up))
- Number of Participants With Acute Procedural Success(At discharge (an average of ≤ 12.3 days post-index procedure))
- Number of Participants With Clip Implant Rate(On the day of index procedure (≤1 day))
- Septal-Lateral Annular Dimension Diastole (SLADd)(60 months)
- Septal-Lateral Annular Dimension Systole (SLADs)(60 months)
- Number of Participants Experiencing Death(12 months visit window (410 days))
- Number of Participants With Incidence of Discharge to a Nursing Home or Skilled Nursing Facility(At discharge (an average of ≤ 12.3 days post-index procedure))
- Number of Participants With MR Severity(5 years)
- Left Ventricular Ejection Fraction (LVEF)(60 months)
- Number of Participants With Hospital Re-admissions(30 days)
- Number of Participants With Second Intervention to Place an Additional Mitraclip Device.(5 years)
- Number of Participants With NYHA Functional Class(5 years)
- Number of Participants With New York Heart Association (NYHA) Functional Class(30 days)
- Left Ventricular Internal Dimension Systole (LVIDs)(60 months)
- Number of Participants With Mitral Stenosis(0 to 5 years)
- Left Ventricular End-diastolic Volume (LVEDV)(60 months)
- Left Ventricular End-systolic Volume (LVESV)(60 months)
- Left Ventricular Internal Dimension Diastole (LVIDd)(60 months)
- Number of Participants With Serious Adverse Events(12 months)
- Procedure Time(On the day of index procedure)
- Number of Participants With MitraClip Devices Implanted(On the day of index procedure)