Actively Recruiting

Age: 18Years - 65Years
All Genders
ID06917586

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

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Received the Mosaic Mitral Valve Bioprosthetic at ProMedica Toledo Hospital
  • Under the age of 65
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Long-term Monitoring

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

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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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