Recruiting

Observational Study

Sponsor:

Michael Moront

Code:

NCT06917586

Conditions

Valve Disease, Heart

Valve Replacement

Valve Regurgitation, Mitral

Valve Heart Stenosis

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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.

Conditions

Valve Disease, Heart

Valve Replacement

Valve Regurgitation, Mitral

Valve Heart Stenosis

Study ID

NCT06917586

Start date

Jan 1, 2025

Status verified date

Feb, 2026

Completion date

Jul 1, 2027

Anticipated

Primary completion date

Jul 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Arms

Mitral Valve Replacement

Patients 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 ]
  • Morbidity [ Time Frame: January 2001 - December 2025 ]

Central Contacts and Locations

Central contacts

Dawn Muskiewicz, MS

419-291-7517dawn.muskiewicz@promedica.org

Leah Stevenson, MS

419-291-3419leah.stevenson@promedica.org

Locations

ProMedica Toledo Hospital

Recruiting

Toledo, Ohio, United States, 43606

Contacts

Dawn Muskiewicz, MS

419-291-7517dawn.muskiewicz@promedica.org

More Information

Sponsor

Michael Moront

Last update posted

Feb 20, 2026

Last verified

Feb, 2026

Keywords

  • Mitral Valve
  • Bioprosthetic
  • Mosaic
  • Valvulopathy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Michael Moront on 2026-02-20.