Mosaic Mitral Valve: Long-Term Outcomes in Patients Under 65

NCT06917586 | Recruiting

• 2 other identifiers: IRB# 24-129ERP-2024-13849
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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

Keywords

Mitral Valve; Bioprosthetic; Mosaic; Valvulopathy

Outcome Measures

Primary Outcomes (2)

• Mortality

  Mortality in patients who were under the age of 65 when receiving the mosaic mitral valve bioprosthetic at ProMedica hospital. Patient records will be reviewed to determine mortality rate of patients who were under 65 years of age when receiving the mosaic mitral valve bioprosthetic.

  From January 2001 to December 2025

• Morbidity

  Post operative morbidity rate for a series of outcomes will be assessed in patients who received the Mosaic mitral valve bioprosthetic over time.

  January 2001 - December 2025

Secondary Outcomes (2)

• Valve Stability

  From January 2001 to December 2025

• Freedom of Re-operation

  January 2001 - December 2025

Study Arms (1)

Mitral Valve Replacement

Patients who have undergone mitral valve replacement at ProMedica Hospital using the mosaic bioprosthesis and were under the age of 65.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study population will include patients who received the mosaic mitral valve bioprosthetic and were between 18-65 years of age at the time of surgery.

You may qualify if:

• Received the Mosaic Mitral Valve Bioprosthetic at ProMedica Toledo Hospital
• Under the age of 65

You may not qualify if:

• Over the age of 65
• Under the age of 18
• Surgery performed at institutions outside of ProMedica Toledo Hospital

Sponsors & Collaborators

• Michael Moront: lead

Study Sites (1)

ProMedica Toledo Hospital

Toledo, Ohio, 43606, United States

RECRUITING

MeSH Terms

Conditions

Heart Valve Diseases; Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Michael Moront, MD

  ProMedica Health System

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dawn Muskiewicz, MS

CONTACT

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

Leah Stevenson, MS

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor Of Medicine

Study Record Dates

• First Submitted: December 16, 2024
• First Posted: April 8, 2025
• Study Start: January 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)