RESTOR-MV: Randomized Evaluation of a Surgical Treatment for Off-Pump Repair of the Mitral Valve

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00120276
Recruitment Status : Completed
First Posted : July 15, 2005
Last Update Posted : May 7, 2009
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Mitral Valve Regurgitation Left Ventricular Dysfunction Heart Failure Device: Less invasive mitral valve repair Phase 2

Detailed Description:
Patient clinical evaluations will consist of 3-month, 6-month, and 12-month follow up of the primary endpoints. Additional follow up of 18-month, 24-month, and annually thereafter will also be included.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Evaluation of a Surgical Treatment for Off-Pump Repair of the Mitral Valve (RESTOR-MV)
Study Start Date : June 2004

Primary Outcome Measures :
  1. 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. [ Time Frame: 12- months ]
  2. 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. [ Time Frame: 12- months ]

Secondary Outcome Measures :
  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 [ Time Frame: 12 months ]

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  • Abnormal coronary or cardiac anatomy such that the device could not be placed without interfering with those anatomical structures.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00120276

United States, Georgia
St. Joseph's Hospital of Atlanta
Atlanta, Georgia, United States
United States, Illinois
Prairie Research and Education Group
Springfield, Illinois, United States
United States, Michigan
St. Joseph's Mercy Hospital
Ann Arbor, Michigan, United States
Covenant Healthcare
Saginaw, Michigan, United States
United States, Nebraska
Nebraska Heart Institute
Lincoln, Nebraska, United States
United States, New York
New York University
New York, New York, United States, 10016
Lenox Hill Hospital
New York, New York, United States, 10021
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27710
United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
VA Pittsburgh
Pittsburgh, Pennsylvania, United States
Sponsors and Collaborators

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Myocor, Inc Identifier: NCT00120276     History of Changes
Other Study ID Numbers: 020202
First Posted: July 15, 2005    Key Record Dates
Last Update Posted: May 7, 2009
Last Verified: May 2008

Keywords provided by Myocor:
Functional Mitral Regurgitation (FMR)
Ischemic Mitral Regurgitation
Less invasive repair
Surgical MV repair
Mitral Valve Repair
Heart Failure
Left Ventricular Dysfunction

Additional relevant MeSH terms:
Heart Failure
Ventricular Dysfunction
Ventricular Dysfunction, Left
Mitral Valve Insufficiency
Heart Diseases
Cardiovascular Diseases
Heart Valve Diseases