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Completed

NCT Number: NCT00120276

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

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.

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Key information

Conditions

Mitral Valve Regurgitation Cardiovascular Diseases Heart Diseases Heart Failure Heart Valve Diseases Left Ventricular Dysfunction Mitral Valve Insufficiency Ventricular Dysfunction Ventricular Dysfunction, Left

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

St. Joseph's Hospital of Atlanta, Atlanta, Georgia, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Less invasive mitral valve repair

Device

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Myocor

Industry

Registry information

Official study title

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

Important dates

Study start
2004
First posted
Jul 15, 2005
Registry last updated
May 7, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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