Mosaic Mitral Valve: Long-Term Outcomes in Patients Under 65
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorMichael Moront
About this trial
The safety and efficacy of the Mosaic bioprosthetic heart valves for cardiac valve replacement in the aortic position has been well documented throughout the literature. However, few studies assessing structural valve deficiency, patient outcomes and overall product performance in patients under the age of 65 exists for the Mosaic mitral valve bioprosthetic. This study aims to assess valve efficacy, stability, and post operative outcomes in patients who have received the Mosaic mitral valve prothesis at ProMedica Toledo Hospital and were under the age of 65.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Received the Mosaic Mitral Valve Bioprosthetic at ProMedica Toledo Hospital
Under the age of 65
Disqualifiers
Over the age of 65
Under the age of 18
Surgery performed at institutions outside of ProMedica Toledo Hospital
Trial population
Study population will include patients who received the mosaic mitral valve bioprosthetic and were between 18-65 years of age at the time of surgery.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
300 Participants
are grouped into 1 trial groupGroup A: Mitral Valve Replacement
Trial outcomes
Primary outcomes
1
Mortality
Mortality in patients who were under the age of 65 when receiving the mosaic mitral valve bioprosthetic at ProMedica hospital. Patient records will be reviewed to determine mortality rate of patients who were under 65 years of age when receiving the mosaic mitral valve bioprosthetic.
Time frame
From January 2001 to December 20252
Morbidity
Post operative morbidity rate for a series of outcomes will be assessed in patients who received the Mosaic mitral valve bioprosthetic over time.
Time frame
January 2001 - December 2025Secondary outcomes
1
Valve Stability
Assess valve stability in patients who received a mosaic mitral valve bioprosthetic at ProMedica Toledo Hospital. Valve stability will be assessed by reviewing post operative echocardiographic data.
Time frame
From January 2001 to December 20252
Freedom of Re-operation
A survival analysis for freedom of reoperation will be assessed for patients who were under 65 at the time of mitral valve replacement.
Time frame
January 2001 - December 2025Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Michael Moront
Lead sponsor
ProMedica Health System
Sponsor institution
Source ClinicalTrials.gov