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

Myocor

Status and phase

Completed

Phase 2

Conditions

Mitral Valve Regurgitation

Heart Failure

Left Ventricular Dysfunction

Treatments

Device: Less invasive mitral valve repair

Study type

Interventional

Funder types

Industry

Identifiers

NCT00120276

020202

Details and patient eligibility

About

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.

Full 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.

Enrollment

250 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No 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.