Long-term outcomes of the Mosaic mitral valve in patients under 65
Long Term Patient Outcomes and Product Durability of the Mosaic Mitral Valve Bioprosthesis in Patients Under 65
This study looks at how well the Mosaic mitral valve works over time in people under 65 who have had valve replacement surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | ProMedica Health System Academic / other |
| Locations | 1 site (Toledo, Ohio) |
| Trial ID | NCT06917586 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the long-term efficacy and stability of the Mosaic bioprosthetic mitral valve in patients under the age of 65 who have undergone valve replacement at ProMedica Toledo Hospital. It aims to assess patient outcomes, including the incidence of structural valve deterioration and overall performance of the valve. The study addresses a gap in existing literature regarding younger patients, as most research has focused on older populations. By analyzing these outcomes, the study seeks to provide valuable insights into the durability and effectiveness of this specific valve type in a younger demographic.
Who should consider this trial
Good fit: Ideal candidates for this study are patients under 65 years old who have received the Mosaic mitral valve bioprosthetic at ProMedica Toledo Hospital.
Not a fit: Patients over the age of 65 or those who had their surgery performed at institutions other than ProMedica Toledo Hospital may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide critical information on the long-term performance of the Mosaic mitral valve, potentially improving treatment decisions for younger patients with valve disease.
How similar studies have performed: While studies have documented the efficacy of bioprosthetic valves in older populations, this specific focus on younger patients with the Mosaic mitral valve is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Received the Mosaic Mitral Valve Bioprosthetic at ProMedica Toledo Hospital * Under the age of 65 Exclusion Criteria: * Over the age of 65 * Under the age of 18 * Surgery performed at institutions outside of ProMedica Toledo Hospital
Where this trial is running
Toledo, Ohio
- ProMedica Toledo Hospital — Toledo, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Michael Moront, MD — ProMedica Health System
- Study coordinator: Dawn Muskiewicz, MS
- Email: dawn.muskiewicz@promedica.org
- Phone: 419-291-7517
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.