Clinical trial NCT00120276: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: 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
Lead sponsor: Myocor
Sponsor class: INDUSTRY
First posted: 2005-07-15
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: 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.
timeFrame: 12- months
measure: 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.
timeFrame: 12- months
Secondary outcomes:
measure: 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
timeFrame: 12 months
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: St. Joseph's Hospital of Atlanta
state: Georgia
city: Springfield
country: United States
facility: Prairie Research and Education Group
state: Illinois
city: Ann Arbor
country: United States
facility: St. Joseph's Mercy Hospital
state: Michigan
city: Saginaw
country: United States
facility: Covenant Healthcare
state: Michigan
city: Lincoln
country: United States
facility: Nebraska Heart Institute
state: Nebraska
city: New York
country: United States
facility: New York University
state: New York
city: New York
country: United States
facility: Lenox Hill Hospital
state: New York
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: VA Pittsburgh
state: Pennsylvania
Study officials:
References:
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.
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.