Mitral Valve Insufficiency
Conditions
Brief summary
The primary goal of the study is to document the number of patients that are successfully implanted and benefit from the implantation of both a CG Future Annuloplasty ring or a band.
Interventions
DEVICECG Future Annuloplasty Ring/Band
A CG Future Annuloplasty Ring or Band will be implanted, following standard care
Sponsors
Medtronic Cardiac Rhythm and Heart Failure
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Signed and dated the Patient Informed Consent (PIC); * Indicated to have a surgical repair for a given degree of moderate to severe mitral valve regurgitation; * Willing to return to the implanting hospital for a 9 month follow-up visit
Exclusion criteria
* Unwilling or inability to sign the PIC; * Already participating in another investigational device study, if this would create bias and jeopardize scientific appropriate assessment of the current study endpoints; * Life expectancy of less than one year; * Pregnant or desire to be pregnant within 12 months of the study treatment; * Less than 18 years and more than 85 years of age.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Identification of the patient population for which a CG Future Annuloplasty Ring or Band is chosen to repair the mitral valve insufficiency | Within 3 months prior to implantation |
| The percentage of patients that are chronically relieved from mitral valve insufficiency | Within 3 months prior to implantation and at 9 month follow-up |
| The level of mitral valve regurgitation | Within 3 months prior to implantation and at 9 month follow-up |
Countries
Belgium, Germany, Greece, Norway, Poland
Outcome results
None listed