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

NCT ID: NCT06917586

Last Updated: 2025-04-08

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-01-01
• Study Completion Date: 2027-07-01

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.

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.

Conditions

Valve Disease, Heart; Valve Replacement; Valve Regurgitation, Mitral; Valve Heart Stenosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Mitral Valve Replacement

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

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Michael Moront

OTHER

Sponsor Role: lead

Responsible Party

Michael Moront

Doctor Of Medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Michael Moront, MD

Role: PRINCIPAL_INVESTIGATOR

ProMedica Health System

Locations

ProMedica Toledo Hospital

Toledo, Ohio, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Dawn Muskiewicz, MS

Role: CONTACT

dawn.muskiewicz@promedica.org

419-291-7517

Leah Stevenson, MS

Role: CONTACT

leah.stevenson@promedica.org

419-291-3419

Facility Contacts

Dawn Muskiewicz, MS

Role: primary

dawn.muskiewicz@promedica.org

419-291-7517

Other Identifiers

ERP-2024-13849

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IRB# 24-129

Identifier Type: -

Identifier Source: org_study_id