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Defining Exercise Hemodynamics and Function After Transcatheter Aortic Valve Replacement (DEFINE-TAVR) Study. (DEFINE-TAVR)

  • Study HIC#:2000033211
  • Last Updated:09/01/2023

The purpose of this study is to help understand how the replacement valve functions over time, both at rest and during exercise.

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    Trial Purpose and Description

    The objective of this single-center registry is to evaluate prosthetic valve hemodynamics and function over time in patients undergoing clinically indicated transcatheter aortic valve replacement (TAVR) for symptomatic severe aortic stenosis. Specific goals include:

    • Describe valve hemodynamics at rest (baseline, post-procedure, 30 days, 1 year) and with exercise (at 30 days and 1 year) after TAVR implantation to define valve function and hemodynamics over time.
    • Compare valve hemodynamics and function at rest and exercise between self-expanding and balloon expandable valves.

    Eligibility Criteria

    Study Population

    A minimum of 50 and up to 100 adults presenting with symptomatic severe aortic stenosis referred for clinically indicated TAVR at Yale New Haven Hospital who meet all eligibility criteria.

    Inclusion Criteria:

    • Male or non-pregnant female ≥18 years of age
    • Clinically indicated for TAVR
    • Aortic annular size measures 21-25 mm diameter based on pre-procedure Computed Tomography Angiography (CTA)
    • Able to exercise and, in the judgment of the investigator, is likely to be physically able to comply with the protocol requirements regarding exercise echocardiography
    • Willing to comply with protocol-specified follow-up evaluations
    • The participant or legally authorized representative, has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent, approved by the appropriate Institutional Review Board (IRB) or Ethics Committee (EC)

    Exclusion Criteria:

    • Previously implanted prosthetic aortic valve (i.e., planned valve-in-valve TAVR)
    • Known mental or physical illness or known history of substance abuse that may cause non-compliance with the protocol, confound the data interpretation, or is associated with a life expectancy of less than one year
    • Left ventricular ejection fraction (LVEF) <35%
    • Presenting with cardiogenic shock at the time of the index procedure
    • Planned to undergo any cardiac surgical procedure in the following 12 months
    • The index procedure results in an unsuccessful TAVR, defined as procedural major adverse events (death, disabling stroke, or life-threatening or disabling bleeding), need for a second prosthesis implant, or conversion to emergent surgery