Real-world Clinical Outcomes of the MITRIS RESILIA Mitral Valve (MOMENTIS)

Edwards Lifesciences

Status: Enrolling

Conditions: Mitral Valve Insufficiency; Mitral Stenosis

Treatments: Device: MITRIS RESILIA Mitral Valve, Model 11400M

Study type: Observational

Funder types: Industry

Identifiers

NCT05526560

2022-09

Details and patient eligibility

About

Collect real-world data on acute and long-term safety and performance of the MITRIS RESILIA Mitral Valve, Model 11400M, in subjects requiring replacement of their native or prosthetic mitral valve with or without concomitant procedures.

Full description

MOMENTIS is a prospective, observational, single-arm, multicenter global study designed to collect real-world clinical outcomes in up to 500 subjects who have received the MITRIS RESILIA Mitral Valve, Model 11400M.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years or older at the time of informed consent
• Has a dysfunctional native or prosthetic mitral valve and requires mitral valve replacement surgery
• Provides written informed consent
• Willingness to follow protocol requirements

Exclusion criteria

• Active endocarditis 3 months prior to the procedure

• Stage 4 renal disease or requiring dialysis

• Less than 2-year life expectancy due to non-cardiovascular life-threatening disease

• High predicted risk of mortality prior to procedure

  • Society of Thoracic Surgeons (STS) Predicted Risk of Mortality (PROM) score of > 8 or
  • Surgeon estimated risk of mortality of > 8

Trial design

500 participants in 1 patient group

Patients requiring replacement of their native or prosthetic mitral valve

Description:

Patients requiring replacement of their native or prosthetic mitral valve

Treatment:

Device: MITRIS RESILIA Mitral Valve, Model 11400M