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NCT Number: NCT05526560

Real-world Clinical Outcomes of the MITRIS RESILIA Mitral Valve

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Mitral Stenosis Cardiovascular Diseases Heart Diseases Heart Valve Diseases Mitral Valve Insufficiency Mitral Valve Stenosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

St. Paul's Hospital and Vancouver General Hospital, Vancouver, British Columbia, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MITRIS RESILIA Mitral Valve, Model 11400M

Device

Replacement of mitral valve with MITRIS RESLIA Mitral Valve

Primary outcomes

  1. Freedom from valve related death or valve related reintervention

    Time frame: 1 year

    Freedom from valve related death or valve related reintervention at 1 year as determined by the Clinical Events Committee

  2. Hemodynamic performance as measured by peak and mean gradient by echocardiography

    Time frame: 1 year

    Hemodynamic performance at 1 year as confirmed by echocardiography and Echo Core Lab evaluation

Secondary outcomes

  1. Early rates of major cardiac events

    Time frame: 0 to 30 days

    Early (<=30 days) rates of major cardiac events

  2. Late linearized rates of major cardiac events

    Time frame: >30 days and up through 10 years post implant

    Linearized rates of late (>30 days) major cardiac events

  3. Functional improvement from baseline for New York Heart Association (NYHA) Class

    Time frame: Annually up to 10 years post implant

    Functional improvement from baseline for NYHA Class

  4. Improvement from baseline for Quality of Life

    Time frame: 1, 3, 5, 8, and 10 years post implant

    Improvement from baseline for Quality of Life as measured by the Short Form (36) Health Survey (SF-36v2) (0-100 scale, with a higher score indicating less disability)

Sponsors and collaborators

Lead sponsor

Edwards Lifesciences

Industry

Registry information

Official study title

A Prospective, Global Study Designed to Collect Real-world Clinical Outcomes of the MITRIS RESILIA Mitral Valve

Acronym: MOMENTIS

Important dates

Study start
2023
Primary completion
2028
Study completion
2035
First posted
Sep 2, 2022
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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