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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.
Conditions:
🦠 Mitral Stenosis 🦠 Mitral Valve Insufficiency
🗓️ Study Start (Actual) 11 January 2023
🗓️ Primary Completion (Estimated) January 2028
✅ Study Completion (Estimated) December 2035
👥 Enrollment (Estimated) 500
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Birmingham, Alabama, United States
📍 Los Angeles, California, United States
📍 Newport Beach, California, United States
📍 Palo Alto, California, United States
📍 Orlando, Florida, United States
📍 Athens, Georgia, United States
📍 Atlanta, Georgia, United States
📍 Carmel, Indiana, United States
📍 Ann Arbor, Michigan, United States
📍 Rochester, Minnesota, United States
📍 Saint Louis, Missouri, United States
📍 New York, New York, United States
📍 New York, New York, United States
📍 New York, New York, United States
📍 Durham, North Carolina, United States
📍 Philadelphia, Pennsylvania, United States
📍 Pittsburgh, Pennsylvania, United States
📍 Pittsburgh, Pennsylvania, United States
📍 Nashville, Tennessee, United States
📍 Nashville, Tennessee, United States
📍 Salt Lake City, Utah, United States
📍 Eau Claire, Wisconsin, United States
📍 Milwaukee, Wisconsin, United States
📍 Vancouver, British Columbia, Canada
📍 London, Ontario, Canada
📍 Montréal, Quebec, Canada
📍 Québec, Canada
📍 München, Germany
More locations available...

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 25 August 2022
  • First Submitted that Met QC Criteria 30 August 2022
  • First Posted 2 September 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 10 July 2024
  • Last Update Posted 11 July 2024
  • Last Verified July 2024
I'm interested ...!!