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(352) 733-0111

Resilience

  • Status
    Accepting Candidates
  • Age
    18 Years - 64 Years
  • Sexes
    All
  • Healthy Volunteers
    No
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Objective

The objective of this observational trial is to determine time to valve failure due to valve deterioration requiring re-intervention and collect/investigate early potential predictors of valve durability (e.g., calcification and hemodynamic deterioration) in RESILIA tissue valves.

Description

Multicenter, prospective, non-randomized, single-arm, observational trial. Subjects will be evaluated at 5, 7, 9, and 11 years post-implant. Up to two hundred fifty (250) total subjects at up to fifteen (15) investigational sites will be enrolled.

Details

Full study title Prospective non-randomized single arm multi-center evaluation of the durability of aortic bioprostheses/valves with RESILIA tissue in subjects under 65
Protocol number OCR16249
ClinicalTrials.gov ID NCT03680040

Eligibility

Inclusion Criteria:

  1. 18 years or older

  2. Subject currently has an Edwards pericardial aortic bioprosthesis with RESILIA tissue

  3. Provides voluntary written informed consent prior to the first trial related procedure

  4. Subject agrees to attend follow-up assessments as specified in the protocol

Exclusion Criteria:

  1. Age 65 years or older at time of aortic valve replacement

  2. The Subject is pregnant or planning to become pregnant at the time of screening

  3. Re-intervention required on the bioprosthetic aortic valve prior to screening

  4. Active endocarditis or history of endocarditis on bioprosthetic aortic valve

  5. Estimated life expectancy

Lead researcher

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  1. Step
    1

    Contact the research team

    Call or email the research team listed within the specific clinical trial or study to let them know that you're interested. A member of the research team, such as the researcher or study coordinator, will be available to tell you more about the study and to answer any questions or concerns you may have.

    Primary contact

  2. Step
    2

    Get screened to confirm eligibility

    You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.

  3. Step
    3

    Provide your consent to participate

    If you are eligible and want to join the clinical trial or study, a member of the research team will ask for your consent to participate. To give consent, you will be asked to read and sign a consent form for the study. This consent form explains the study's purpose, procedures, risks, benefits and provides other important information, such as the study team's contact information.

  4. Step
    4

    Participate

    If you decide to participate in a clinical trial or study, the research team will keep you informed of the study requirements and what you will need to do to throughout the study. For some trials or studies, your health care provider may work with the research team to ensure there are no conflicts with other medications or treatments.