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

May 5, 2009 updated by: Myocor

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Device: Less invasive mitral valve repair

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

Enrollment (Anticipated)

250

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	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. Time Frame: 12- months	12- months

Secondary Outcome Measures

Outcome Measure	Time Frame
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	12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Myocor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2004

Study Registration Dates

First Submitted

July 7, 2005

First Submitted That Met QC Criteria