N/A
N=965
Real World Expanded Multicenter Study of the MitraClip® System (REALISM)
Mitral Valve Insufficiency · Mitral Valve Regurgitation · Mitral Valve Incompetence · Mitral Regurgitation · Mitral Insufficiency
Bottom Line
View on ClinicalTrials.gov: NCT01931956 ↗Enrolled (actual)
965
Serious AEs
83.5%
Results posted
Jun 2017
Primary outcome: Primary: Number of Participants With Major Adverse Events — 5; 3; 98; 31 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- MitraClip® implant (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Abbott Medical Devices
- Primary completion
- Feb 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Major Adverse Events |
31; 5; 223; 74 | — |
| PRIMARY Number of Participants With Major Adverse Events |
31; 5; 223; 74 | — |
| PRIMARY Number of Participants With 12-Month Efficacy |
25; 1; 339; 166 | — |
| SECONDARY Number of Participants With Serious Adverse Events |
37; 7; 388; 131 | — |
| SECONDARY Number of Participants With Serious Adverse Events |
37; 7; 388; 131 | — |
| SECONDARY Number of Participants With Clinically Significant Atrial Septal Defect (ASD) |
3; 0; 22; 15 | — |
| SECONDARY Number of Participants With Clinically Significant Atrial Septal Defect (ASD) |
3; 0; 22; 15 | — |
| SECONDARY Number of Participants With Major Adverse Events (MAE) in Patients Over 75 Years of Age |
3; 2; 64; 16 | — |
| SECONDARY Number of Participants With Major Adverse Events in Patients Over 75 Years of Age |
12; 4; 146; 40 | — |
| SECONDARY Number of Participants With Major Adverse Events in Patients Over 75 Years of Age |
12; 4; 146; 40 | — |
| SECONDARY Number of Participants With Major Adverse Events in Patients Over 75 Years of Age |
12; 4; 146; 40 | — |
| SECONDARY Number of Participants With Major Adverse Events in Patients Over 75 Years of Age |
12; 4; 146; 40 | — |
| SECONDARY Number of Participants With Major Adverse Events in Patients Over 75 Years of Age |
12; 4; 146; 40 | — |
| SECONDARY Number of Participants With Acute Procedural Success |
41; 3; 524; 229 | — |
| SECONDARY Number of Participants With Procedural Success |
45; 4; 541; 239 | — |
| SECONDARY Number of Participants With Clinical Durability |
22; 0; 325; 163 | — |
| SECONDARY Number of Participants With Clip Implant Rate |
55; 7; 603; 258 | — |
| SECONDARY Procedure Time |
141.7; 123.6; 139.0; 137.8 | — |
| SECONDARY Device Time |
115.1; 96.6; 106.8; 111.5 | — |
| SECONDARY Fluoroscopy Duration |
42.5; 33.6; 38.5; 34.6 | — |
| SECONDARY Number of Participants With MitraClip Devices Implanted |
4; 0; 25; 13; 30; 5 | — |
| SECONDARY Post-Procedure Intensive Care Unit (ICU)/ Critical Care Unit (CCU)/ Post-anesthesia Care Unit (PACU) Duration |
22.1; 149.3; 36.5; 28.8 | — |
| SECONDARY Post-Procedure Length of Hospital Stay |
2.4; 12.3; 3.2; 2.8 | — |
| SECONDARY Number of Participants Experiencing Death |
13; 2; 97; 13; 7; 3 | — |
| SECONDARY Number of Participants With Incidence of Discharge to a Nursing Home or Skilled Nursing Facility |
51; 0; 523; 248; 3; 2 | — |
| SECONDARY Number of Participants With Hospital Re-admissions |
7; 1; 74; 15 | — |
| SECONDARY Number of Participants With Device Embolization or Single Leaflet Device Attachment (SLDA) |
0; 1; 13; 11 | — |
| SECONDARY Number of Participants With Mitral Stenosis |
3; 0; 7; 6 | — |
| SECONDARY Number of Participants With Mitral Regurgitation (MR) Severity |
0; 0; 7; 1; 22; 1 | — |
| SECONDARY Number of Participants With MR Severity |
0; 0; 2; 4; 4; 0 | — |
| SECONDARY Number of Participants With MR Severity |
0; 0; 2; 4; 4; 0 | — |
| SECONDARY Number of Participants With MR Severity |
0; 0; 2; 4; 4; 0 | — |
| SECONDARY Number of Participants With MR Severity |
0; 0; 2; 4; 4; 0 | — |
| SECONDARY Number of Participants With MR Severity |
0; 0; 2; 4; 4; 0 | — |
| SECONDARY Number of Participants With Second Intervention to Place an Additional Mitraclip Device. |
1; 0; 33; 11 | — |
| SECONDARY Number of Participants With Second Intervention to Place an Additional Mitraclip Device. |
1; 0; 33; 11 | — |
| SECONDARY Number of Participants With New York Heart Association (NYHA) Functional Class |
17; 0; 163; 113; 22; 2 | — |
| SECONDARY Number of Participants With NYHA Functional Class |
1; 0; 52; 65; 3; 0 | — |
| SECONDARY Number of Participants With NYHA Functional Class |
1; 0; 52; 65; 3; 0 | — |
| SECONDARY Number of Participants With NYHA Functional Class |
1; 0; 52; 65; 3; 0 | — |
| SECONDARY Number of Participants With NYHA Functional Class |
1; 0; 52; 65; 3; 0 | — |
| SECONDARY Number of Participants With NYHA Functional Class |
1; 0; 52; 65; 3; 0 | — |
| SECONDARY Left Ventricular End-diastolic Volume (LVEDV) |
146.1; 125.9 | — |
| SECONDARY Left Ventricular End-diastolic Volume (LVEDV) |
146.1; 125.9 | — |
| SECONDARY Left Ventricular End-diastolic Volume (LVEDV) |
146.1; 125.9 | — |
| SECONDARY Left Ventricular End-diastolic Volume (LVEDV) |
146.1; 125.9 | — |
| SECONDARY Left Ventricular End-diastolic Volume (LVEDV) |
146.1; 125.9 | — |
| SECONDARY Left Ventricular End-diastolic Volume (LVEDV) |
146.1; 125.9 | — |
| SECONDARY Left Ventricular End-systolic Volume (LVESV) |
85.4; 59.0 | — |
| SECONDARY Left Ventricular End-systolic Volume (LVESV) |
85.4; 59.0 | — |
| SECONDARY Left Ventricular End-systolic Volume (LVESV) |
85.4; 59.0 | — |
| SECONDARY Left Ventricular End-systolic Volume (LVESV) |
85.4; 59.0 | — |
| SECONDARY Left Ventricular End-systolic Volume (LVESV) |
85.4; 59.0 | — |
| SECONDARY Left Ventricular End-systolic Volume (LVESV) |
85.4; 59.0 | — |
| SECONDARY Left Ventricular Internal Dimension Diastole (LVIDd) |
5.4; 5.3 | — |
| SECONDARY Left Ventricular Internal Dimension Diastole (LVIDd) |
5.4; 5.3 | — |
| SECONDARY Left Ventricular Internal Dimension Diastole (LVIDd) |
5.4; 5.3 | — |
| SECONDARY Left Ventricular Internal Dimension Diastole (LVIDd) |
5.4; 5.3 | — |
| SECONDARY Left Ventricular Internal Dimension Diastole (LVIDd) |
5.4; 5.3 | — |
| SECONDARY Left Ventricular Internal Dimension Diastole (LVIDd) |
5.4; 5.3 | — |
| SECONDARY Left Ventricular Internal Dimension Systole (LVIDs) |
4.2; 3.7 | — |
| SECONDARY Left Ventricular Internal Dimension Systole (LVIDs) |
4.2; 3.7 | — |
| SECONDARY Left Ventricular Internal Dimension Systole (LVIDs) |
4.2; 3.7 | — |
| SECONDARY Left Ventricular Internal Dimension Systole (LVIDs) |
4.2; 3.7 | — |
| SECONDARY Left Ventricular Internal Dimension Systole (LVIDs) |
4.2; 3.7 | — |
| SECONDARY Left Ventricular Internal Dimension Systole (LVIDs) |
4.2; 3.7 | — |
| SECONDARY Left Ventricular Ejection Fraction (LVEF) |
46.3; 55.5 | — |
| SECONDARY Left Ventricular Ejection Fraction (LVEF) |
46.3; 55.5 | — |
| SECONDARY Left Ventricular Ejection Fraction (LVEF) |
46.3; 55.5 | — |
| SECONDARY Left Ventricular Ejection Fraction (LVEF) |
46.3; 55.5 | — |
| SECONDARY Left Ventricular Ejection Fraction (LVEF) |
46.3; 55.5 | — |
| SECONDARY Left Ventricular Ejection Fraction (LVEF) |
46.3; 55.5 | — |
| SECONDARY Septal-Lateral Annular Dimension Diastole (SLADd) |
3.9; 4.0 | — |
| SECONDARY Septal-Lateral Annular Dimension Diastole (SLADd) |
3.9; 4.0 | — |
| SECONDARY Septal-Lateral Annular Dimension Diastole (SLADd) |
3.9; 4.0 | — |
| SECONDARY Septal-Lateral Annular Dimension Diastole (SLADd) |
3.9; 4.0 | — |
| SECONDARY Septal-Lateral Annular Dimension Diastole (SLADd) |
3.9; 4.0 | — |
| SECONDARY Septal-Lateral Annular Dimension Diastole (SLADd) |
3.9; 4.0 | — |
| SECONDARY Septal-Lateral Annular Dimension Systole (SLADs) |
3.4; 3.5 | — |
| SECONDARY Septal-Lateral Annular Dimension Systole (SLADs) |
3.4; 3.5 | — |
| SECONDARY Septal-Lateral Annular Dimension Systole (SLADs) |
3.4; 3.5 | — |
| SECONDARY Septal-Lateral Annular Dimension Systole (SLADs) |
3.4; 3.5 | — |
| SECONDARY Septal-Lateral Annular Dimension Systole (SLADs) |
3.4; 3.5 | — |
| SECONDARY Septal-Lateral Annular Dimension Systole (SLADs) |
3.4; 3.5 | — |
Summary
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).
Eligibility Criteria
Patients screened in EVEREST II REALISM Study will first be screened for high risk (HR) status and enrolled into the HR arm if they meet eligibility for this arm of the study. If they do not meet eligibility for the HR arm, patients will be further screened for eligibility for enrollment into the non-high risk (NHR) arm.
Key Inclusion Criteria
- 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 2.5 mg/dL 9.2 Prior chest surgery 9.3 Age over 75 9.4 EF 25% LVEF and LVESD ≤55mm or, 2. 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
Key Exclusion Criteria
- 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 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 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 2.5mg/dL
Data sourced from ClinicalTrials.gov (NCT01931956). 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.