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

This study has been completed.
Sponsor:
Information provided by:
Myocor
ClinicalTrials.gov Identifier:
NCT00120276
First received: July 7, 2005
Last updated: May 5, 2009
Last verified: May 2008
  Purpose

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 Intervention Phase
Mitral Valve Regurgitation
Left Ventricular Dysfunction
Heart Failure
Device: Less invasive mitral valve repair
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Evaluation of a Surgical Treatment for Off-Pump Repair of the Mitral Valve (RESTOR-MV)

Resource links provided by NLM:


Further study details as provided by Myocor:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 250
Study Start Date: June 2004
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00120276

Locations
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
Myocor
  More Information

No publications provided by Myocor

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Myocor, Inc
ClinicalTrials.gov Identifier: NCT00120276     History of Changes
Other Study ID Numbers: 020202
Study First Received: July 7, 2005
Last Updated: May 5, 2009
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 22, 2014