N/A
Completed N=279
Pivotal Study of a Percutaneous Mitral Valve Repair System
Mitral Valve Insufficiency · Mitral Valve Regurgitation · Mitral Valve Incompetence · Mitral Regurgitation
Source: ClinicalTrials.gov NCT00209274 ↗
Enrolled (actual)
279
Serious AEs
70.2%
Results posted
Sep 2017
Primary outcomePrimary: Number of Participants With Major Adverse Events (MAE) — 13; 45 Participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Major Adverse Events (MAE) |
39; 44 | — |
| PRIMARY Number of Participants With Freedom From Surgery for Valve Dysfunction, Death, and Moderate to Severe (3+) or Severe (4+) Mitral Regurgitation (MR). |
87; 55 | — |
| SECONDARY Freedom From All-Cause Mortality |
81.2; 79 | — |
| SECONDARY Number of Participants With Freedom From Surgery for Valve Dysfunction, Death, and Moderate to Severe (3+) or Severe (4+) Mitral Regurgitation. |
118; 65 | — |
| SECONDARY Number of Participants With Freedom From Surgery for Valve Dysfunction, Death, and Moderate to Severe (3+) or Severe (4+) Mitral Regurgitation (MR). |
87; 55 | — |
| SECONDARY 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 |
100; 56 | — |
| SECONDARY Left Ventricular Ejection Fraction (LVEF) |
56.5; 57 | — |
| SECONDARY Left Ventricular Status- Left Ventricular End-diastolic Volume (LVEDV), Left Ventricular End-systolic Volume (LVESV) |
144.7; 130.8; 63.7; 62.0 | — |
| SECONDARY Left Ventricular Status- LVEDV, LVESV |
126.3; 112.9; 56.1; 50.1 | — |
| SECONDARY Left Ventricular Internal Dimension Systole (LVIDs) |
3.6; 3.3 | — |
| SECONDARY Left Ventricular Internal Dimension Diastole (LVIDd) |
5.2; 4.9 | — |
| SECONDARY Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease. |
70; 33; 27; 8; 9; 1 | — |
| SECONDARY New York Heart Association (NYHA) Functional Class Cardiac Disease: NYHA Functional Class III or IV |
10.1; 9.3 | — |
| SECONDARY Percentage of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease: NYHA Functional Class III or IV |
8.5; 2.4 | — |
| SECONDARY Short Form (SF)-36 Quality of Life Questionnaire. |
46.8; 46.5; 52.9; 50.4 | — |
| SECONDARY Cardiac Output |
4.0; 4.1 | — |
| SECONDARY Cardiac Index |
2.1; 2.1 | — |
| SECONDARY Cardiac Index (CI) |
2.3; 2.4 | — |
| SECONDARY Regurgitant Volume |
19.4; 15.7 | — |
| SECONDARY Regurgitant Fraction (RF) |
25.4; 17.3 | — |
| SECONDARY Regurgitant Fraction |
24.5; 20.4 | — |
| SECONDARY Number of Participants With Clip Implant Rate |
158 | — |
| SECONDARY Number of Participants With Acute Procedural Success |
137 | — |
| SECONDARY Number of Participants With Acute Surgical Success |
80 | — |
| SECONDARY Number of Participants With Successful Clip Implant and Acute Procedural Success |
158; 137 | — |
| SECONDARY Number of Participants With Mitral Valve Repair Success. |
103; 46 | — |
| SECONDARY Number of Participants With Procedural Freedom From In-hospital MAE. |
168; 41 | — |
| SECONDARY Number of Participants With Procedural Freedom From In-hospital MAE |
10; 39 | — |
| SECONDARY Number of Participants With MAE: Surgery After Device and First Time Surgery Control |
14; 40 | — |
| SECONDARY Number of Participants With Major Vascular Complications |
11; 0 | — |
| SECONDARY Number of Participants With Major Bleeding Complications. |
17; 39 | — |
| SECONDARY Number of Participants With Major Adverse Events (MAE) |
39; 44 | — |
| SECONDARY Number of Participants With MAE in Patients Over 75 Years of Age. |
14; 14 | — |
| SECONDARY Number of Participants With Dysrhythmia |
22; 22 | — |
| SECONDARY Number of Participants With Endocarditis. |
2; 1 | — |
| SECONDARY Number of Participants With Thrombosis. |
0; 0 | — |
| SECONDARY Number of Participants With Hemolysis |
0; 0 | — |
| SECONDARY Number of Participants With Clinically Significant Atrial Septal Defect (ASD). |
2; 0 | — |
| SECONDARY Number of Participants With Clinically Significant Atrial Septal Defect (ASD) |
4; 0 | — |
| SECONDARY Number of Participants With Mitral Valve Stenosis |
4; 2; 1; 0 | — |
| SECONDARY Mitral Valve Area by Planimetry |
3.2; 3.7 | — |
| SECONDARY Mitral Valve Area by Planimetry Index |
1.7; 1.8 | — |
| SECONDARY Mitral Valve Area by Pressure Half-time |
2.7; 2.8 | — |
| SECONDARY Mitral Valve Area by Pressure Half-time Index |
1.4; 1.5 | — |
| SECONDARY Transvalvular Mitral Valve Gradient |
3.3; 3.1 | — |
| SECONDARY Transvalvular Mitral Mean Pressure Gradient (Mean MVG) |
3.0; 3.0 | — |
| SECONDARY Post-procedure Length of Hospital Stay |
2.6; 7.5 | — |
| SECONDARY Post-procedure Intensive Care Unit (ICU) / Critical Care Unit (CCU) Duration |
38.6; 82.3 | — |
| SECONDARY Number of Participants With Hospital Re-admissions |
24; 14 | — |
| SECONDARY Number of Participants With Incidence of Discharge to a Nursing Home or Skilled Nursing Facility/Hospital |
6; 12 | — |
| SECONDARY Number of Participants With Incidence of Hospital Readmissions for Congestive Heart Failure (CHF). |
2; 2 | — |
| SECONDARY Number of Participants With New Coumadin (Warfarin) Usage |
36; 33 | — |
| SECONDARY Number of Participants With Durability of the MitraClip Device and Surgery. |
0; 2; 0; 1; 4; 0 | — |
| SECONDARY Number of Participants With Freedom From Death, Mitral Valve Surgery/Re-operation and MR > 2+ |
96; 62 | — |
| SECONDARY Number of Participants With Freedom From Mitral Valve Surgery/Re-operation |
135; 75 | — |
| SECONDARY Number of Participants With Freedom From Death and Mitral Valve Surgery/Re-operation |
111; 61 | — |
| SECONDARY Number of Participants With MitraClip Device Embolization/Single Leaflet Device Attachment |
0; 0 | — |
| SECONDARY Number of Participants With Non-cerebral Thromboembolism. |
1; 2 | — |
| SECONDARY Number of Participants With MR Severity |
4; 6; 49; 32; 34; 2 | — |
| SECONDARY Number of Participants With Incidence of Mitral Valve Replacement |
17; 14 | — |
Eligibility Criteria
Key Inclusion/Exclusion Criteria:
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
Data sourced from ClinicalTrials.gov (NCT00209274). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.