Mitral Valve RegurgitationPhase 2NCT00120276
RESTOR-MV: Randomized Evaluation of a Surgical Treatment for Off-Pump Repair of the Mitral Valve
A Phase 2 study testing Less invasive mitral valve repair in people with Mitral Valve Regurgitation and Left Ventricular Dysfunction, run by Myocor at 10 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Mitral Valve Regurgitation, Left Ventricular Dysfunction, Heart Failure
- What is being tested?
- Less invasive mitral valve repair
- Type of treatment
- Medical device
- How many people
- 250 participants
- Where
- 10 sitesUnited States
- Study dates
- Jun 2004to not given
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 16Show fewer
- 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.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
St. Joseph's Mercy Hospital
Ann Arbor, Michigan
St. Joseph's Hospital of Atlanta
Atlanta, Georgia
Duke University
Durham, North Carolina, 27710
Nebraska Heart Institute
Lincoln, Nebraska
New York University
New York, New York, 10016
Lenox Hill Hospital
New York, New York, 10021
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania
VA Pittsburgh
Pittsburgh, Pennsylvania
Covenant Healthcare
Saginaw, Michigan
Prairie Research and Education Group
Springfield, Illinois
About this study
Official title: Randomized Evaluation of a Surgical Treatment for Off-Pump Repair of the Mitral Valve (RESTOR-MV)
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.
Read the 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.
- Being tested
- Less invasive mitral valve repair
- Keywords
- Functional Mitral Regurgitation (FMR), Ischemic Mitral Regurgitation, Less invasive repair, Surgical MV repair, Mitral Valve Repair, Heart Failure, Left Ventricular Dysfunction
- Medical subject headings
- Mitral Valve Insufficiency, Ventricular Dysfunction, Left, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Less invasive mitral valve repairDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2005 (estimated)
- Study startJun 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mitral Valve RegurgitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Myocor
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00120276
- Sponsor's protocol ID
- 020202
- Status last verified
- May 2008
- First submitted
- 7 Jul 2005
- Last updated
- 7 May 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 21168015Grossi 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.
PubMed 21126639
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Evaluation of a Surgical Treatment for Off-Pump Repair of the Mitral Valve (RESTOR-MV)
- ClinicalTrials.gov ID
- NCT00120276
- Acronym / sponsor ID
- 020202
- Keywords
- Functional Mitral Regurgitation (FMR), Ischemic Mitral Regurgitation, Less invasive repair, Surgical MV repair, Mitral Valve Repair, Heart Failure, Left Ventricular Dysfunction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- MyocorIndustry (pharma, biotech, devices)
- Study start
- Jun 2004
- First posted
- 15 Jul 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Less invasive mitral valve repair | Device | – |
Primary outcome
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
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2009.
- Derived from this study: PubMed 21168015Grossi 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.
- Derived from this study: PubMed 21126639Grossi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Less invasive mitral valve repair in people with Mitral Valve Regurgitation and Left Ventricular Dysfunction, run by Myocor at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 12- months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00120276, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2009.