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

Primary Purpose

Mitral Valve Regurgitation, Left Ventricular Dysfunction, Heart Failure

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Less invasive mitral valve repair
Sponsored by
Myocor
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mitral Valve Regurgitation focused on measuring Functional Mitral Regurgitation (FMR), Ischemic Mitral Regurgitation, Less invasive repair, Surgical MV repair, Mitral Valve Repair, Heart Failure, Left Ventricular Dysfunction

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • St. Joseph's Hospital of Atlanta
  • Prairie Research and Education Group
  • St. Joseph's Mercy Hospital
  • Covenant Healthcare
  • Nebraska Heart Institute
  • New York University
  • Lenox Hill Hospital
  • Duke University
  • Hospital of the University of Pennsylvania
  • VA Pittsburgh

Outcomes

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.
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.

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

Full Information

First Posted
July 7, 2005
Last Updated
May 5, 2009
Sponsor
Myocor
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1. Study Identification

Unique Protocol Identification Number
NCT00120276
Brief Title
RESTOR-MV: Randomized Evaluation of a Surgical Treatment for Off-Pump Repair of the Mitral Valve
Official Title
Randomized Evaluation of a Surgical Treatment for Off-Pump Repair of the Mitral Valve (RESTOR-MV)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Myocor

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mitral Valve Regurgitation, Left Ventricular Dysfunction, Heart Failure
Keywords
Functional Mitral Regurgitation (FMR), Ischemic Mitral Regurgitation, Less invasive repair, Surgical MV repair, Mitral Valve Repair, Heart Failure, Left Ventricular Dysfunction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Less invasive mitral valve repair
Primary Outcome Measure Information:
Title
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
Title
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 Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
St. Joseph's Hospital of Atlanta
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
Prairie Research and Education Group
City
Springfield
State/Province
Illinois
Country
United States
Facility Name
St. Joseph's Mercy Hospital
City
Ann Arbor
State/Province
Michigan
Country
United States
Facility Name
Covenant Healthcare
City
Saginaw
State/Province
Michigan
Country
United States
Facility Name
Nebraska Heart Institute
City
Lincoln
State/Province
Nebraska
Country
United States
Facility Name
New York University
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Lenox Hill Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
VA Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21168015
Citation
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.
Results Reference
derived
PubMed Identifier
21126639
Citation
Grossi 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.
Results Reference
derived

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

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