Real-world Clinical Outcomes of the MITRIS RESILIA Mitral Valve

(MOMENTIS Trial)

Recruiting at 32 trial locations

Overseen By Sabrina Hundt, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Edwards Lifesciences

Disqualifiers: Endocarditis, Stage 4 renal, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 0 to 30 days

500 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Gorav Ailawadi, MD

Principal Investigator

University of Michigan

Eligibility Criteria

Inclusion Criteria

Has a dysfunctional native or prosthetic mitral valve and requires mitral valve replacement surgery

Provides written informed consent

Willingness to follow protocol requirements

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the MITRIS RESILIA Mitral Valve replacement

0 to 30 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

10 years

Treatment Details

Interventions

• MITRIS RESILIA Mitral Valve, Model 11400M

Participant Groups

Group I: Patients requiring replacement of their native or prosthetic mitral valve Experimental Treatment 1 Intervention

Patients requiring replacement of their native or prosthetic mitral valve

Who Is Running the Clinical Trial?

Edwards Lifesciences

Lead Sponsor

Trials

188

Recruited

67,500+

Founded

1958

Headquarters

Irvine, California, U.S.

Known For

Structural Heart Innovations

Top Products

SAPIEN Transcatheter Heart Valve, EVOQUE System, PASCAL Precision, SAPIEN M3

Todd Brinton

Edwards Lifesciences

Chief Medical Officer since 2023

MD from Stanford University

Bernard Zovighian

Edwards Lifesciences

Chief Executive Officer since 2023

MBA from INSEAD