MITRIS China Post Market Clinical Follow-up (PMCF) Study

Edwards Lifesciences

Status: Enrolling

Conditions: Mitral Valve Replacement

Treatments: Device: MITRIS RESILIA Mitral Valve

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT07059793

2024-14

Details and patient eligibility

About

Collect clinical outcomes 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

The trial is a Multicenter, prospective, single-arm, post-market study designed to collect clinical outcomes in up to 250 Subjects who have received the MITRIS RESILIA Mitral Valve, Model 11400M.

Enrollment: 250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 18 years or older at the time of informed consent
2. Has a dysfunctional native or prosthetic mitral valve and requires mitral valve replacement surgery
3. Provide signed written informed consent prior to the study participation
4. Willingness to follow protocol requirements

Exclusion criteria

1. Active endocarditis 3 months prior to the procedure
2. Stage 4 renal disease or requiring dialysis (eGFR < 30 is excluded)
3. Less than 2-year life expectancy due to non-cardiovascular life-threatening disease
4. High predicted risk of mortality prior to procedure - STS Predicted Risk of Mortality (PROM) > 8 or Surgeon estimated risk of mortality of > 8 (STS PROM risk calculation score must be used for patients undergoing Isolated Mitral Valve Replacement (MVR) or MVR+ Coronary Artery Bypass Grafting (CABG). Surgeon estimated risk of mortality may only be used for patients who do not qualify for evaluation against those surgical models.)
5. Participating in a drug or device study that has not reached its primary endpoint. Note: Participation in national registries is not an exclusion.

Trial design

250 participants in 1 patient group

MITRIS RESILIA Mitral Valve

Description:

Subjects who received the MITRIS RESILIA Mitral Valve, Model 11400M

Treatment:

Device: MITRIS RESILIA Mitral Valve