Real World Expanded Multicenter Study of the MitraClip® System (REALISM)
REALISM
A Continued Access Registry of the Evalve® MitraClip® System: EVEREST II Real World Expanded Multicenter Study of the MitraClip System (REALISM)
2 other identifiers
interventional
965
1 country
38
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2009
Longer than P75 for not_applicable
38 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 22, 2009
CompletedFirst Submitted
Initial submission to the registry
August 27, 2013
CompletedFirst Posted
Study publicly available on registry
August 30, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedResults Posted
Study results publicly available
June 19, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2018
CompletedDecember 4, 2018
November 1, 2018
6 years
August 27, 2013
November 17, 2016
November 5, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Number of Participants With Major Adverse Events
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, gastro-intestinal (GI) complication requiring surgery, new onset of permanent atrial fibrillation, septicemia and transfusion of 2 or more units of blood.
30 days
Number of Participants With Major Adverse Events
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.
12 months
Number of Participants With 12-Month Efficacy
Defined as freedom from: Surgery for Mitral Regurgitation (MR) or Valve Dysfunction, death, and MR \> 2+ (moderate to severe (3+) or severe MR (4+)).
12 months
Secondary Outcomes (81)
Number of Participants With Serious Adverse Events
30 days
Number of Participants With Serious Adverse Events
12 months
Number of Participants With Clinically Significant Atrial Septal Defect (ASD)
30 days
Number of Participants With Clinically Significant Atrial Septal Defect (ASD)
12 months
Number of Participants With Major Adverse Events (MAE) in Patients Over 75 Years of Age
30 days
- +76 more secondary outcomes
Other Outcomes (5)
36-Item Short Form Health Survey (SF-36) Quality of Life Change From Baseline to 30 Days
30 days
36-Item Short Form Health Survey (SF-36) Quality of Life Change From Baseline to 12 Months
12 months
Change in 6-Minute Walk Test (6MWT)
At Baseline and 30 Days
- +2 more other outcomes
Study Arms (4)
Non-High Risk
EXPERIMENTALIncludes 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.
High Risk
EXPERIMENTALIncludes 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.
Compassionate Use
EXPERIMENTALPatients 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.
Emergency Use
EXPERIMENTALPatients 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.
Interventions
Percutaneous mitral valve repair using MitraClip implant
Eligibility Criteria
You may qualify if:
- 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
- +5 more criteria
You may not qualify if:
- 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
- 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
- +20 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (38)
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
El Camino Hospital
Mountain View, California, 94040, United States
University of California Davis Medical Center
Sacramento, California, 95817, United States
University of Colorado Health Sciences Center
Aurora, Colorado, 80045, United States
Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
Baptist Hospital of Miami, FL
Miami, Florida, 33176, United States
Piedmont Hospital
Atlanta, Georgia, 30309, United States
St. Joseph's Hospital
Atlanta, Georgia, 30342, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
Evanston Hospital
Evanston, Illinois, 60201, United States
The Care Group Medical Center (St. Vincent Hospital)
Indianapolis, Indiana, 46290, United States
Shawnee Mission Medical Center
Shawnee Mission, Kansas, 66204, United States
Terrebonne General Medical Center
Houma, Louisiana, 70360, United States
Maine Medical Center
Portland, Maine, 04102, United States
William Beaumont Hospital
Royal Oak, Michigan, 48073, United States
Minneapolis Heart Institute
Minneapolis, Minnesota, 55407, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
St. Patrick's Hospital & Health Science Center
Missoula, Montana, 59802, United States
Morristown Memorial Hospital
Morristown, New Jersey, 07960, United States
New York University Medical Center
New York, New York, 10016, United States
Columbia University Medical Center
New York, New York, 10032, United States
New York Presbyterian Hospital
New York, New York, 10032, United States
Lenox Hill Hospital
New York, New York, 10075, United States
St. Francis Hospital
Roslyn, New York, 11576, United States
Carolina's Medical Center (Sanger Clinic)
Charlotte, North Carolina, 28203, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
East Carolina Heart Institute
Greenville, North Carolina, 27834, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Oklahoma Heart Hospital
Oklahoma City, Oklahoma, 73120, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Baylor University Medical Center
Dallas, Texas, 75226, United States
Memorial Hermann Hospital
Houston, Texas, 77024, United States
University of Texas Health Science Center
San Antonio, Texas, 78229, United States
Intermountain Medical Center
Murray, Utah, 84107, United States
University of Virginia Health System
Charlottesville, Virginia, 22903, United States
Swedish Medical Center
Seattle, Washington, 98122, United States
St. Luke's Medical Center
Milwaukee, Wisconsin, 53215, United States
Related Publications (6)
Grayburn PA, Roberts BJ, Aston S, Anwar A, Hebeler RF Jr, Brown DL, Mack MJ. Mechanism and severity of mitral regurgitation by transesophageal echocardiography in patients referred for percutaneous valve repair. Am J Cardiol. 2011 Sep 15;108(6):882-7. doi: 10.1016/j.amjcard.2011.05.013. Epub 2011 Jul 7.
PMID: 21741608RESULTPope NH, Lim S, Ailawadi G. Late calcific mitral stenosis after MitraClip procedure in a dialysis-dependent patient. Ann Thorac Surg. 2013 May;95(5):e113-4. doi: 10.1016/j.athoracsur.2012.10.067.
PMID: 23608290RESULTGlower DD, Kar S, Trento A, Lim DS, Bajwa T, Quesada R, Whitlow PL, Rinaldi MJ, Grayburn P, Mack MJ, Mauri L, McCarthy PM, Feldman T. Percutaneous mitral valve repair for mitral regurgitation in high-risk patients: results of the EVEREST II study. J Am Coll Cardiol. 2014 Jul 15;64(2):172-81. doi: 10.1016/j.jacc.2013.12.062.
PMID: 25011722RESULTAilawadi G, Lim DS, Mack MJ, Trento A, Kar S, Grayburn PA, Glower DD, Wang A, Foster E, Qasim A, Weissman NJ, Ellis J, Crosson L, Fan F, Kron IL, Pearson PJ, Feldman T; EVEREST II Investigators. One-Year Outcomes After MitraClip for Functional Mitral Regurgitation. Circulation. 2019 Jan 2;139(1):37-47. doi: 10.1161/CIRCULATIONAHA.117.031733.
PMID: 30586701DERIVEDWang A, Sangli C, Lim S, Ailawadi G, Kar S, Herrmann HC, Grayburn P, Foster E, Weissman NJ, Glower D, Feldman T. Evaluation of renal function before and after percutaneous mitral valve repair. Circ Cardiovasc Interv. 2015 Jan;8(1):e001349. doi: 10.1161/CIRCINTERVENTIONS.113.001349.
PMID: 25593120DERIVEDLim DS, Reynolds MR, Feldman T, Kar S, Herrmann HC, Wang A, Whitlow PL, Gray WA, Grayburn P, Mack MJ, Glower DD. Improved functional status and quality of life in prohibitive surgical risk patients with degenerative mitral regurgitation after transcatheter mitral valve repair. J Am Coll Cardiol. 2014 Jul 15;64(2):182-92. doi: 10.1016/j.jacc.2013.10.021. Epub 2013 Oct 31.
PMID: 24184254DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jeffrey T Ellis
- Organization
- Abbott Vascular
Study Officials
- STUDY DIRECTOR
Ted Feldman, M.D. Feldman, M.D.
Endeavor Health
- STUDY DIRECTOR
Donald D Glower Jr., MD
Duke University
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 27, 2013
First Posted
August 30, 2013
Study Start
January 22, 2009
Primary Completion
February 1, 2015
Study Completion
June 1, 2018
Last Updated
December 4, 2018
Results First Posted
June 19, 2017
Record last verified: 2018-11