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 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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
ProMedica Toledo HospitalToledoOhio43606
Dawn Muskiewicz, MS
419-291-7517

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