Pivotal Study of a Percutaneous Mitral Valve Repair System (EVERESTIIRCT)
Recruitment status was: Active, not recruiting
|Mitral Valve Insufficiency Mitral Valve Regurgitation Mitral Valve Incompetence Mitral Regurgitation Mitral Insufficiency||Device: Percutaneous mitral valve repair using MitraClip implant Procedure: Mitral valve repair or replacement surgery|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Pivotal Study: A Study of the Evalve Cardiovascular Valve Repair System - Endovascular Valve Edge-to-Edge REpair STudy (EVERESTIIRCT)|
- Freedom from surgery for valve dysfunction, death, and moderate to severe (3+) or severe (4+) mitral regurgitation (MR). [ Time Frame: 12 months ]
- Major adverse events (MAE) [ Time Frame: 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.
- Major adverse events (MAE) [ Time Frame: 12 months. ]
- Major bleeding complications. [ Time Frame: 30 days and 12 months. ]Major Bleeding Complications defined as procedure related bleeding that requires a transfusion of ≥2 units of blood products and/or surgical intervention at 30 days or hospital
- Non-cerebral thromboembolism. [ Time Frame: 30 days and 12 months. ]Defined as any thrombus or thromboembolism in the vasculature (excluding central nervous system events) or on the investigational device or any commercially available implant used during surgery confirmed by standard clinical and laboratory testing and which requires treatment.
- Endocarditis. [ Time Frame: 30 days and 12 months. ]Defined as a diagnosis of endocarditis based on the Duke criteria.From The American College of Cardiology (ACC)/American Heart Association (AHA) Guidelines for the Management of Patients with Valvular Heart Disease, Journal of the American College of Cardiology (JACC), Vol 32, No.5,November 1, 1998:pg1541, Table 21
- Thrombosis. [ Time Frame: 30 days and 12 months. ]Defined as evidence of the formation of an independently moving thrombus on any part of the MitraClip or any commercially available implant used during surgery by echocardiography or fluoroscopy.
- Hemolysis. [ Time Frame: 30 days and 12 months. ]
Defined as new onset of anemia associated with laboratory evidence of red cell destruction. Diagnosed when plasma free hemoglobin is greater than 40 mg/dL on repeat measures within 24 hours or on one measure if intervention is initiated based on other clinical symptoms.
Reported as major or minor as defined below:
Major: Requires intervention with red blood cell transfusion or other hematocrit increasing measures in the absence of other obvious bleeding. Minor: Does not require intervention.
- Clinically significant Atrial septal defect (ASD). [ Time Frame: 30 days and 12 months. ]Defined as a significant residual atrial septal opening. Reported as clinically significant if intervention is performed for the primary purpose of repairing the ASD. If cardiac surgery is indicated for reasons other than residual ASD (e.g., residual MR) and the ASD is repaired at the same time, this does not meet the definition of clinically significant ASD.
- Mitral Valve stenosis. [ Time Frame: 30 days and 12 months. ]Defined as a mitral valve planimetered orifice area of less than 1.5 cm2 as measured by echocardiography.
- New York Heart Association (NYHA) functional class cardiac disease. [ Time Frame: 30 days, 6 months and 12 months ]Class I Patients with cardiac disease but without resulting limitations of physical activity. Class II Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain. Class III Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain. Class IV Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.
- Acute procedural success [ Time Frame: 30 Days ]Defined as successful MitraClip implantation with resulting MR of 2+ or less.
- Post-procedure length of hospital stay. [ Time Frame: 30 Days ]
- Post-procedure intensive care unit (ICU) / critical care unit (CCU)/(post-anesthesia care unit) PACU duration. [ Time Frame: 30 Days ]
- Short Form (SF)-36 Quality of Life questionnaire. [ Time Frame: 30 days and 12 months ]
- MAE in patients over 75 years of age. [ Time Frame: 12 months ]
- Mitral valve repair success. [ Time Frame: 12 months ]Defined as freedom from mitral valve replacement surgery for Valve Dysfunction, death, re-operation, and MR > 2+ at 12 months.
- Procedural success [ Time Frame: 30 days ]Defined as successful implant of the Clip(s) with resulting MR severity ≤ 2 at discharge or 1 grade MR reduction at discharge accompanied by 1 level NYHA reduction.
- Freedom from surgery for valve dysfunction, death, and moderate to severe (3+) or severe (4+) mitral regurgitation. [ Time Frame: 18 and 24 months ]
- Clip implant rate [ Time Frame: Day 0 ]defined as the rate of successful implantation of MitraClip(s).
- Procedural freedom from MAE. [ Time Frame: Day 0 ]
- Acute surgical success [ Time Frame: 30 Days ]Defined as successful mitral valve repair or replacement.
- Left Ventricular Status [ Time Frame: 30 days and 12 months ]Left Ventricular Status is defined a including including Left ventricular (LV) ejection fraction (EF), LV end-diastolic volume (LVEDV), LV end-systolic volume (LVESV), LV internal dimension systole (LVIDs), and LV internal dimension diastole (LVIDd) as determined by the core echo laboratory at 30 days or hospital discharge, whichever is longer, and 12 months.
- Incidence of hospital readmissions for congestive heart failure (CHF). [ Time Frame: 12 months pre- versus post-MitraClip ]
- Number of days hospitalized for CHF. [ Time Frame: 12 months pre- versus post-MitraClip ]
- 6 Minute Walk Test. [ Time Frame: 30 days, 6 months, 12 months ]
- Major vascular [ Time Frame: 30 days and 12 months. ]
Vascular Complications defined as the occurrence of any of the following resulting through 30 days or hospital discharge, whichever is longer:
- Hematoma at access site >6 cm.;
- Retroperitoneal hematoma;
- Arteriovenous (AV) fistula;
- Symptomatic peripheral ischemia/ nerve injury or the clinical signs or symptoms lasting >48 hours;
- Vascular Surgical Repair at catheter access sites;
- Pulmonary embolism;
- Ipsilateral deep vein thrombus; or
- Access site-related infection requiring intravenous antibiotics and/or extended hospitalization.
- Cardiac output [ Time Frame: 30 days and 12 months ]Cardiac output as measured by core lab echocardiography
- Cardiac index [ Time Frame: 30 days and 12 months ]Defined as cardiac index (cardiac output divided by body surface area) as measured by core lab echocardiography
- Incidence of new Coumadin (warfarin) usage [ Time Frame: 30 days and 6 months ]
- Incidence of discharge to a nursing home or skilled nursing facility. [ Time Frame: 30 Days ]
- Mitral valve index [ Time Frame: 30 Days ]Defined as mitral valve area divided by body surface area as measured by core lab echocardiography.
- Mitral valve area [ Time Frame: 30 Days ]Defined as mitral valve area as measured by core lab echocardiography.
- Transvalvular flow gradient [ Time Frame: 30 Days ]Peak and Mean
- Regurgitant volume [ Time Frame: 30 Days ]Regurgitant volume as determined by the core echo laboratory.
- Regurgitant fraction [ Time Frame: 30 Days ]Regurgitant fraction as determined by the core echo laboratory.
- Incidence of mitral valve replacement [ Time Frame: 30 Days and 12 months ]
- Hospital re-admissions [ Time Frame: 30 Days and 12 months ]
|Study Start Date:||May 2005|
|Estimated Study Completion Date:||December 2014|
|Primary Completion Date:||November 2009 (Final data collection date for primary outcome measure)|
Percutaneous mitral valve repair using MitraClip implant. The expected number of patients in the device arm is 186 (172 evaluable)
Device: Percutaneous mitral valve repair using MitraClip implant
Other Name: MitraClip
Active Comparator: 2
Mitral valve repair or replacement surgery.The expected number of patients in the active comparator arm is 93 (86 evaluable).
Procedure: Mitral valve repair or replacement surgery
Repair or replacement of mitral valve
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00209274
|United States, Illinois|
|Evanston Northwestern Healthcare|
|Evanston, Illinois, United States, 60201|
|Principal Investigator:||Ted Feldman, M.D.||NorthShore University HealthSystem Research Institute|
|Principal Investigator:||Donald G Glower Jr., MD||Duke University Medical Center, Department of Surgery|