RESTOR-MV: Randomized Evaluation of a Surgical Treatment for Off-Pump Repair of the Mitral Valve
Randomized Evaluation of a Surgical Treatment for Off-Pump Repair of the Mitral Valve (RESTOR-MV)
1 other identifier
interventional
250
1 country
10
Brief Summary
The purpose of this prospective, randomized, multi-center, pivotal trial is to compare the safety and effectiveness of the off-pump, closed heart Coapsys System (Myocor, Inc.) to open surgical repair of the mitral valve using an annuloplasty ring or band in patients with moderate to severe functional mitral regurgitation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2004
CompletedFirst Submitted
Initial submission to the registry
July 7, 2005
CompletedFirst Posted
Study publicly available on registry
July 15, 2005
CompletedMay 7, 2009
May 1, 2008
July 7, 2005
May 5, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Primary effectiveness endpoint to compare the mean change in MR grade in the Coapsys group to the open-heart annuloplasty group from baseline to 12 months.
12- months
The primary safety endpoint is to compare the rate of primary adverse events (PAE's) through 12 months in the Coapsys group to the PAE rate in the open-heart annuloplasty group.
12- months
Secondary Outcomes (1)
Compare heart failure symptoms, left ventricular geometry, change in MR and TR, adverse events, and hospitalization time and costs of Coapsys group to control group
12 months
Interventions
Eligibility Criteria
You may qualify if:
- Grade 2, 3, or 4 functional mitral valve regurgitation per 2D echocardiography
- Patient undergoing concomitant coronary artery bypass graft surgery, either on-pump or off-pump
- Left ventricular ejection fraction greater than or equal to 25%
- Age between 18 and 80 years, inclusive
- Patient is willing and available to return for study follow up
- Ability of the patient or legal representative to understand and provide signed consent for participating in the study.
You may not qualify if:
- Structural abnormality of the mitral valve (e.g. calcification or thickening of the valve leaflets, ruptured papillary muscle, ruptured chordae tendinae, mitral valve prolapse, mitral stenosis, etc.)
- Asymptomatic Grade 2 MR (those with NYHA Class \< II AND LVEF \> 40%)
- Organic valve disease resulting in insufficiency or stenosis of the aortic, pulmonary or tricuspid valve requiring surgical intervention
- Transmural myocardial infarction within 30 day period prior to surgical placement of Coapsys
- NYHA class IV
- Left ventricular end diastolic diameter \> 7.0 cm
- Cardiac surgery on an emergency or salvage basis
- Left atrial or left ventricular thrombus
- Left ventricular aneurysm
- Previous mitral valve surgery or other previous cardiac surgery that would preclude proper placement of the Coapsys
- Chronic renal failure requiring dialysis
- Open chest surgery contraindication (e.g., acute respiratory distress, endocarditis, myocarditis, pericarditis)
- Active infection
- Life expectancy of less than 24 months due to conditions other than their cardiac status
- Participation in another investigational drug or device protocol
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Myocorlead
Study Sites (10)
St. Joseph's Hospital of Atlanta
Atlanta, Georgia, United States
Prairie Research and Education Group
Springfield, Illinois, United States
St. Joseph's Mercy Hospital
Ann Arbor, Michigan, United States
Covenant Healthcare
Saginaw, Michigan, United States
Nebraska Heart Institute
Lincoln, Nebraska, United States
New York University
New York, New York, 10016, United States
Lenox Hill Hospital
New York, New York, 10021, United States
Duke University
Durham, North Carolina, 27710, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
VA Pittsburgh
Pittsburgh, Pennsylvania, United States
Related Publications (2)
Grossi EA, Woo YJ, Patel N, Goldberg JD, Schwartz CF, Subramanian VA, Genco C, Goldman SM, Zenati MA, Wolfe JA, Mishra YK, Trehan N. Outcomes of coronary artery bypass grafting and reduction annuloplasty for functional ischemic mitral regurgitation: a prospective multicenter study (Randomized Evaluation of a Surgical Treatment for Off-Pump Repair of the Mitral Valve). J Thorac Cardiovasc Surg. 2011 Jan;141(1):91-7. doi: 10.1016/j.jtcvs.2010.08.057.
PMID: 21168015DERIVEDGrossi EA, Patel N, Woo YJ, Goldberg JD, Schwartz CF, Subramanian V, Feldman T, Bourge R, Baumgartner N, Genco C, Goldman S, Zenati M, Wolfe JA, Mishra YK, Trehan N, Mittal S, Shang S, Mortier TJ, Schweich CJ Jr; RESTOR-MV Study Group. Outcomes of the RESTOR-MV Trial (Randomized Evaluation of a Surgical Treatment for Off-Pump Repair of the Mitral Valve). J Am Coll Cardiol. 2010 Dec 7;56(24):1984-93. doi: 10.1016/j.jacc.2010.06.051.
PMID: 21126639DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 7, 2005
First Posted
July 15, 2005
Study Start
June 1, 2004
Last Updated
May 7, 2009
Record last verified: 2008-05