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

Sponsor

Myocor (Industry)

Overall Status

Completed

CT.gov ID

NCT00120276

Collaborator

(none)

250

Enrollment

Locations

Patients Per Site

Study Details

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.

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 Design

Study Type:

Interventional

Anticipated 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 :

Jun 1, 2004

Outcome Measures

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. [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 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 [12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	St. Joseph's Hospital of Atlanta	Atlanta	Georgia	United States
2	Prairie Research and Education Group	Springfield	Illinois	United States
3	St. Joseph's Mercy Hospital	Ann Arbor	Michigan	United States
4	Covenant Healthcare	Saginaw	Michigan	United States
5	Nebraska Heart Institute	Lincoln	Nebraska	United States
6	New York University	New York	New York	United States	10016
7	Lenox Hill Hospital	New York	New York	United States	10021
8	Duke University	Durham	North Carolina	United States	27710
9	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania	United States
10	VA Pittsburgh	Pittsburgh	Pennsylvania	United States