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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00120276
• Other study ID #: 020202
• Status: Completed
• Phase: Phase 2
• First received: July 7, 2005
• Last updated: May 5, 2009
• Start date: June 2004

Study information

• Verified date: May 2008
• Source: Myocor
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure
• Left Ventricular Dysfunction
• Mitral Valve Insufficiency
• Mitral Valve Regurgitation
• Ventricular Dysfunction
• Ventricular Dysfunction, Left

Intervention

Device:
• Less invasive mitral valve repair

Locations

Country	Name	City	State
United States	St. Joseph's Mercy Hospital	Ann Arbor	Michigan
United States	St. Joseph's Hospital of Atlanta	Atlanta	Georgia
United States	Duke University	Durham	North Carolina
United States	Nebraska Heart Institute	Lincoln	Nebraska
United States	Lenox Hill Hospital	New York	New York
United States	New York University	New York	New York
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	VA Pittsburgh	Pittsburgh	Pennsylvania
United States	Covenant Healthcare	Saginaw	Michigan
United States	Prairie Research and Education Group	Springfield	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Myocor

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	Yes
Secondary	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	No