Actively Recruiting
Long Term Patient Outcomes and Product Durability of the Mosaic Mitral Valve Bioprosthesis in Patients Under 65
Led by Michael Moront · Updated on 2026-02-20
300
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the long-term outcomes and durability of the Medtronic Mosaic mitral valve bioprosthesis in patients under 65 years of age who have undergone mitral valve replacement. While the safety and effectiveness of this bioprosthetic valve in the aortic position are well documented, fewer studies have examined its performance and patient outcomes in the mitral position, especially in younger patients where mechanical valves are more commonly recommended. This study seeks to provide valuable information on valve efficacy, stability, and post-operative results for this specific group. The study focuses on patients who received the Mosaic mitral valve bioprosthesis at ProMedica Toledo Hospital and were under the age of 65 at the time of surgery. It observes these patients over time to assess valve durability and patient health outcomes. There are no experimental treatments or interventions since this is an observational study reviewing existing cases. The investigation covers multiple years, analyzing data from January 2001 through December 2025. Participants' involvement includes monitoring mortality, morbidity, valve stability, and freedom from re-operation over the study period. Researchers will collect and review medical records and follow-up data to measure these outcomes. The study will help understand how well the valve performs in the mitral position among younger patients and aims to inform future treatment choices and valve replacement timing. The total observation period extends until July 1, 2027.
CONDITIONS
Brief Title
Mosaic Mitral Valve: Long-Term Outcomes in Patients Under 65
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Received the Mosaic Mitral Valve Bioprosthetic at ProMedica Toledo Hospital
- Under the age of 65
You will not qualify if you...
- Over the age of 65
- Under the age of 18
- Surgery performed at institutions outside of ProMedica Toledo Hospital
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 years
Participants who have undergone mitral valve replacement with the Mosaic bioprosthetic valve are observed over time to assess valve durability and patient outcomes.
Periodic visits as scheduled during follow-up
Trial Site Locations
Total: 1 location
1
ProMedica Toledo Hospital
Toledo, Ohio, United States, 43606
Actively Recruiting
Research Team
D
Dawn Muskiewicz, MS
L
Leah Stevenson, MS
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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