Clinical trial NCT06917586: Mosaic Mitral Valve: Long-Term Outcomes in Patients Under 65
Official title: Long Term Patient Outcomes and Product Durability of the Mosaic Mitral Valve Bioprosthesis in Patients Under 65
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Valve Disease, Heart
Valve Replacement
Valve Regurgitation, Mitral
Valve Heart Stenosis
Keywords: Mitral Valve
Bioprosthetic
Mosaic
Valvulopathy
Lead sponsor: ProMedica Health System
Sponsor class: OTHER
First posted: 2025-04-08
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Mortality
timeFrame: From January 2001 to December 2025
measure: Morbidity
timeFrame: January 2001 - December 2025
Secondary outcomes:
measure: Valve Stability
timeFrame: From January 2001 to December 2025
measure: Freedom of Re-operation
timeFrame: January 2001 - December 2025
Other outcomes:
Locations:
city: Toledo
country: United States
facility: ProMedica Toledo Hospital
state: Ohio
Study officials:
affiliation: ProMedica Health System
name: Michael Moront, MD
role: PRINCIPAL_INVESTIGATOR
References: