Mitral Valve RegurgitationPhase 3MEMO3DNCT00567853
Safety and Efficacy Study of the Sorin 3D Annuloplasty Ring For Mitral Repair
A Phase 3 study testing Implantation of the MEMO 3D Annuloplasty Ring in people with Mitral Valve Regurgitation, run by Sorin Group USA, Inc. at 6 sites in 2 countries.
Trial summary
The purpose of this study is to collect data on the effectiveness and clinical outcomes of the MEMO 3D Annuloplasty ring as used for mitral valve repair. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Valve Regurgitation
- What is being tested?
- Implantation of the MEMO 3D Annuloplasty Ring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 278 participants
- Where
- 6 sitesin 2 countries
- Study dates
- Aug 2007to Jun 2013
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject is 18 years old or older
- An annuloplasty ring is indicated for reinforcement of a dysfunctional or diseased native mitral valve according to the current medical practice for valvular repair at each site.
- The subject is able to return for all follow-up evaluations of the study.
Who cannot join
- The subject or subject's legal representative is unwilling to sign the informed consent.
- The subject is or will be participating in another medical device or drug clinical trial.
- The subject is a minor, prisoner, institutionalized, or is unable to give informed consent.
- The subject has a life expectance of less than 1 year.
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
United States4 sites
Minneapolis Heart Institute
Minneapolis, Minnesota, 55407
University of Pennsylvania Presbyterian Hospital
Philadelphia, Pennsylvania, 19104
The Heart Hospital Baylor Plano
Plano, Texas, 75093
Barnes Jewish Hospital
St Louis, Missouri, 63100
Canada2 sites
Foothills Medical Centre
Calgary, Alberta, T2N 2T9
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, B3H 3A7
About this study
Official title: Clinical Investigation Of The Sorin 3D Annuloplasty Ring For Mitral Repair
The purpose of this study is to collect data on the effectiveness and clinical outcomes of the MEMO 3D Annuloplasty ring as used for mitral valve repair.
- Conditions
- Mitral Valve Regurgitation
- Being tested
- Implantation of the MEMO 3D Annuloplasty Ring
- Keywords
- mitral valve regurgitation, mitral valve disease, mitral valve repair, mitral valve dysfunction, heart valve, valve disease, cardiac surgery
- Medical subject headings
- Mitral Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantation of the MEMO 3D Annuloplasty RingDevice
Implantation of the MEMO 3D Annulopalsty Ring for mitral valve repair.
| Study group | Role | What they receive |
|---|---|---|
| MEMO 3D ring | Other | All patients in the study will be implanted with the MEMO 3D ring Receives: Device: Implantation of the MEMO 3D Annuloplasty Ring |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of patients with successful repair at 6 months.
Measured: One Year
Secondary outcomes (1)
Freedom from re-operation at 12 months. Preoperative and postoperative mitral valve regurgitation and LV dimensions and mass assessed by echocardiography. Actuarial survival and freedom from clinical events at 12 months.
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 posted5 Dec 2007 (estimated)
- Study startAug 2007
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 278 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sorin Group USA, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clark Hargrove, M.D., Principal investigator, University of Pennsylvania Presbyterian Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00567853
- Sponsor's protocol ID
- MEMO3D.Reg
- Acronym
- MEMO3D
- Status last verified
- Jan 2015
- First submitted
- 4 Dec 2007
- Last updated
- 26 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation Of The Sorin 3D Annuloplasty Ring For Mitral Repair
- ClinicalTrials.gov ID
- NCT00567853
- Acronym / sponsor ID
- MEMO3D / MEMO3D.Reg
- Conditions
- Mitral Valve Regurgitation
- Keywords
- mitral valve regurgitation, mitral valve disease, mitral valve repair, mitral valve dysfunction, heart valve, valve disease, cardiac surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 278 participants (actual)
- Lead sponsor
- Sorin Group USA, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2007
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 5 Dec 2007 (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 study is to collect data on the effectiveness and clinical outcomes of the MEMO 3D Annuloplasty ring as used for mitral valve repair.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MEMO 3D ring | Other | Device: Implantation of the MEMO 3D Annuloplasty RingAll patients in the study will be implanted with the MEMO 3D ring |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The subject is 18 years old or older
- An annuloplasty ring is indicated for reinforcement of a dysfunctional or diseased native mitral valve according to the current medical practice for valvular repair at each site.
- The subject is able to return for all follow-up evaluations of the study.
Key exclusion criteria (4 listed)
- The subject or subject's legal representative is unwilling to sign the informed consent.
- The subject is or will be participating in another medical device or drug clinical trial.
- The subject is a minor, prisoner, institutionalized, or is unable to give informed consent.
- The subject has a life expectance of less than 1 year.
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 |
|---|---|---|
| Implantation of the MEMO 3D Annuloplasty RingImplantation of the MEMO 3D Annulopalsty Ring for mitral valve repair. | Device | MEMO 3D ring |
Primary outcome
The percentage of patients with successful repair at 6 months.
Time frame: One Year
1 secondary outcome
Freedom from re-operation at 12 months. Preoperative and postoperative mitral valve regurgitation and LV dimensions and mass assessed by echocardiography. Actuarial survival and freedom from clinical events at 12 months.
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 26 Jan 2015.
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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.
Clark Hargrove, M.D. principal investigator
University of Pennsylvania Presbyterian Medical Center
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Implantation of the MEMO 3D Annuloplasty Ring in people with Mitral Valve Regurgitation, run by Sorin Group USA, Inc. at 6 sites in 2 countries.
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 3 inclusion and 4 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 26 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Canada. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
The percentage of patients with successful repair at 6 months. (time frame: One Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jan 2015.