Mitral Valve Regurgitation
Conditions
Keywords
mitral valve regurgitation, mitral valve disease, mitral valve repair, mitral valve dysfunction, heart valve, valve disease, cardiac surgery
Brief 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.
Interventions
DEVICEImplantation of the MEMO 3D Annuloplasty Ring
Implantation of the MEMO 3D Annulopalsty Ring for mitral valve repair.
Sponsors
Sorin Group USA, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percentage of patients with successful repair at 6 months. | One Year |
Secondary
| Measure | Time frame |
|---|---|
| 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. | 12 months |
Countries
Canada, United States
Outcome results
None listed