Mitral Valve Insufficiency
Conditions
Brief summary
The goal of the study is to identify the patients suffering from a mitral valve condition who benefit from the implantation of a Profile 3D annuloplasty ring in terms of acute and long-term relief of mitral valve regurgitation.
Interventions
None listed
Sponsors
Medtronic Cardiac Rhythm and Heart Failure
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Indicated for a surgical repair for moderate to severe mitral valve regurgitation at rest (level 2 or higher); * Willing to return to the hospital where the implantation originally occurred as part of the standard practice of care
Exclusion criteria
* Heavily calcified valves * Valvular retraction with severely reduced mobility * Active bacterial endocarditis * Already participating in another investigational device study, possibly leading to bias and jeopardizing the scientific appropriate assessment of the study endpoints; * Life expectancy of less than one year; * Pregnant or desire to be pregnant within 12 months of the study treatment; * Under 18 years or over 85 years of age.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Identify the patient population for which a Profile 3D Annuloplasty Ring is chosen to repair the mitral valve insufficiency. | screening |
| Assess the percentage of patients that are chronically relieved from mitral valve dysfunction | 6-12 months follow up |
| Determine the level of mitral valve regurgitation in patients | 6-12 months post-surgery |
Countries
Canada, Czechia, France, Germany, Italy
Outcome results
None listed