Mosaic Mitral Valve: Long-Term Outcomes in Patients Under 65
Part of paid clinical trials in Toledo, Ohio.
- Sponsor
- Michael Moront
- Study ID
- NCT06917586
- Status
- Recruiting
Conditions
- Valve Disease, Heart
- Valve Heart Stenosis
- Valve Regurgitation, Mitral
- Valve Replacement
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 65 Years
- Healthy Volunteers
- Not accepted
Study Details
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.
Key Dates
- Start date
- Jan 1, 2025
- Status verified
- Feb 2026
- Primary completion
- Jul 1, 2026
- Completion
- Jul 1, 2027
Study Design
- Enrollment
- 300 participants (estimated)
Arms
- Arm: Mitral Valve ReplacementPatients who have undergone mitral valve replacement at ProMedica Hospital using the mosaic bioprosthesis and were under the age of 65.
Primary Outcome Measure
Mortality [ Time Frame: From January 2001 to December 2025 ]
Central Contacts
- Dawn Muskiewicz, MS419-291-7517
- Leah Stevenson, MS419-291-3419
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| ProMedica Toledo Hospital | Toledo | Ohio | 43606 |
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