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

Long Term Patient Outcomes and Product Durability of the Mosaic Mitral Valve Bioprosthesis in Patients Under 65

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.

Study Overview

• Status: Recruiting
• Conditions: Valve Disease, Heart; Valve Replacement; Valve Heart Stenosis; Valve Regurgitation, Mitral

Detailed Description

Background:

Within the U.S., the prevalence of valvular heart disease is estimated at 2.5% with an abrupt increase after the age of 65 years, predominantly due to degenerative etiologies. In patients with significant valve insufficiency or stenosis where repair or reconstruction is not feasible, valve replacement is the most offered solution. The two types of heart valves offered to patients include mechanical or bioprosthetic. The major advantage of bioprosthetic heart valves in comparison to mechanical valves is the lack of post-operative anticoagulant therapy. However, the major disadvantage of bioprosthetic heart valves lie in their reduced durability compared to mechanical valves, with reoperation rates of ~10% at 10 years and up to 30% at 15 years.

The use of porcine bioprosthetic heart valves for cardiac valve replacement first appeared in the late 1960s and have been widely used since due to the avoidance of anticoagulant therapy. One of the major drawbacks associated with bioprosthetic valves is structural valve deterioration (SVD) which can lead to reduced valve durability, necessitating reoperation. The causes of SVD are poorly understood, however, it is thought to result from the accumulation of calcium and lipids on the valve surface. The Medtronic Mosaic mitral bioprosthetic valve is a 3rd-generation, stented porcine heart valve that was originally approved for clinical use in the U.S. in 2000. These valves are treated with a 0.2% glutaraldehyde solution stabilizing the tissue by cross-linking free lysine residues. In addition, the valve is treated with alpha-amino oleic acid (AOATM) which has been shown to mitigate leaflet calcification in animal studies. Long term clinical safety and efficacy of the Mosaic valve in the aortic position is well documented throughout the literature however, few studies exist detailing performance in the mitral position. Moreover, even fewer studies exist detailing overall valve survival in patients under 65 due to the more common recommendation of the use of mechanical valve replacement in this population. The purpose of this study is to examine long-term outcomes in patients who have received the Mosaic mitral valve bioprosthetic and were under the age of 65 at placement.

Significance:

The investigation of the Medtronic mosaic heart valve in the mitral position will allow for a better assessment of product performance and its impact on patient outcomes. Results can inform physicians on the longevity of the product when used in the mitral position allowing for more accurate prediction of replacement time. In addition, the results may provide further information to the safety and efficacy of placement in the mitral position in patients under the age of 65, a population in which mechanical valves are more prevalent.

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Dawn Muskiewicz, MS; Phone Number: 419-291-7517; Email: dawn.muskiewicz@promedica.org
• Study Contact Backup: Name: Leah Stevenson, MS; Phone Number: 419-291-3419; Email: leah.stevenson@promedica.org

Study Locations

• United States
  • Ohio
    • Toledo, Ohio, United States, 43606
      • Recruiting
      • ProMedica Toledo Hospital
      • Contact: Dawn Muskiewicz, MS; Phone Number: 419-291-7517; Email: dawn.muskiewicz@promedica.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Mitral Valve Replacement; Patients who have undergone mitral valve replacement at ProMedica Hospital using the mosaic bioprosthesis and were under the age of 65.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Valve Stability	Assess valve stability in patients who received a mosaic mitral valve bioprosthetic at ProMedica Toledo Hospital. Valve stability will be assessed by reviewing post operative echocardiographic data.	From January 2001 to December 2025
Freedom of Re-operation	A survival analysis for freedom of reoperation will be assessed for patients who were under 65 at the time of mitral valve replacement.	January 2001 - December 2025

Collaborators and Investigators

• Sponsor: Michael Moront
• Investigators: Principal Investigator: Michael Moront, MD, ProMedica Health System

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: December 16, 2024
• First Submitted That Met QC Criteria: March 31, 2025
• First Posted (Actual): April 8, 2025

Study Record Updates

• Last Update Posted (Actual): February 20, 2026
• Last Update Submitted That Met QC Criteria: February 18, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Mosaic; Mitral Valve; Valvulopathy; Bioprosthetic
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Mitral Valve Insufficiency; Heart Valve Diseases
• Other Study ID Numbers: IRB# 24-129; ERP-2024-13849 (Other Grant/Funding Number: Medtronic, Inc)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No