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Completed

NCT Number: NCT05567809

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

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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Key information

Conditions

Aortic Valve Stenosis Aortic Valve Disease Cardiovascular Diseases Heart Diseases Heart Valve Diseases Ventricular Outflow Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Yale New Haven Hospital

New Haven, Connecticut, 06510, United States

About this study

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.

Who can participate

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

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

Treatment and study plan

Primary outcomes

  1. TransAortic Valve Gradient during exercise at 12 months post-TAVR

    Time frame: 12 months post-TAVR

    TransAortic Valve Gradient (mmHg) during exercise as assessed by the Echocardiographic Core Laboratory and summarized as peak and mean.

Secondary outcomes

  1. Change in valve cusp thickness at rest

    Time frame: baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR

    Change in valve cusp thickness (mm) at rest assessed using echocardiogram reported as absolute values and as changes.

  2. Change in valve mobility at rest

    Time frame: baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR

    Change in valve mobility at rest assessed using echocardiogram reported as absolute values and as changes.

  3. Change in paravalvular leak at rest

    Time frame: baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR

    Change in paravalvular leak at rest assessed using echocardiogram reported as absolute values and as changes.

  4. Change in coefficient of contraction Effective Orifice Area (EOA)/Geometric Orifice Area (GOA) at rest

    Time frame: baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR

    Change in coefficient of contraction EOA/GOA at rest assessed using echocardiogram reported as absolute values and as changes.

  5. Change in Dimensionless Velocity Index (DVI) at rest

    Time frame: baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR

    Change in DVI at rest assessed using echocardiogram reported as absolute values and as changes.

  6. Change in energy loss coefficient at rest

    Time frame: baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR

    Change in energy loss coefficient at rest assessed using echocardiogram reported as absolute values and as changes.

  7. Change in EOA at rest

    Time frame: baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR

    Change in EOA (cm2) at rest assessed using echocardiogram reported as absolute values and as changes.

  8. Change in aortic valve gradient (peak and mean) at rest

    Time frame: baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR

    Change in aortic valve gradient (mmHg) (peak and mean) at rest assessed using echocardiogram reported as absolute values and as changes.

  9. Change in aortic valve velocity (peak and mean) at rest

    Time frame: baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR

    Change in aortic valve velocity (m/s) (peak and mean) at rest assessed using echocardiogram reported as absolute values and as changes.

  10. Change in Left Ventricle (LV) remodeling at rest

    Time frame: baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR

    Change in LV remodeling at rest assessed using echocardiogram reported as absolute values and as changes.

  11. Change in leaflet thickening at rest

    Time frame: baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR

    Change in leaflet thickening at rest assessed using echocardiogram reported as absolute values and as changes.

  12. Change in coaptation length at rest

    Time frame: baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR

    Change in coaptation length (mm) at rest assessed using echocardiogram reported as absolute values and as changes.

  13. Change in LV thickness at rest

    Time frame: baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR

    Change in LV thickness (cm) at rest assessed using echocardiogram reported as absolute values and as changes.

  14. Change in LV Global Longitudinal Strain at rest

    Time frame: baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR

    Change in LV Global Longitudinal Strain (%) at rest assessed using echocardiogram reported as absolute values and as changes.

  15. Change in Right Ventricular (RV) systolic velocity at rest

    Time frame: baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR

    Change in RV systolic velocity (cm/s) at rest assessed using echocardiogram reported as absolute values and as changes.

  16. Change in RV systolic pressure (RVSP) at rest

    Time frame: baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR

    Change in RVSP (mmHg) at rest assessed using echocardiogram reported as absolute values and as changes.

  17. Change in Tricuspid Annular Plane Systolic Excursion (TAPSE) at rest

    Time frame: baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR

    Change in TAPSE (mm) at rest assessed using echocardiogram reported as absolute values and as changes.

  18. Change in aortic valve gradient (peak and mean) with exercise

    Time frame: 30 days, and 12 months post-TAVR

    Change in gradient (mmHg) (peak and mean) with exercise assessed using echocardiogram reported as absolute values and as changes.

  19. Change in aortic valve velocity (peak and mean) with exercise

    Time frame: 30 days and 12 months post-TAVR

    Change in aortic valve velocity (m/s) (peak and mean) with exercise assessed using echocardiogram reported as absolute values and as changes.

  20. Change in DVI with exercise

    Time frame: 30 days and 12 months post-TAVR

    Change in DVI with exercise assessed using echocardiogram reported as absolute values and as changes.

  21. Change in EOA with exercise

    Time frame: 30 days and 12 months post-TAVR

    Change in EOA (cm2) with exercise assessed using echocardiogram reported as absolute values and as changes.

  22. Change in RVSP with exercise

    Time frame: 30 days and 12 months post-TAVR

    Change in RVSP (mmHg) with exercise assessed using echocardiogram reported as absolute values and as changes.

  23. Change in exercise duration

    Time frame: 30 days and 12 months post-TAVR

    Change in exercise duration (min) reported as absolute values and as changes.

  24. Change in LV Global Longitudinal Strain with exercise

    Time frame: 30 days and 12 months post-TAVR

    Change in LV Global Longitudinal Strain (%) with exercise assessed using echocardiogram reported as absolute values and as changes.

  25. TAVR Device Success (Valve Academic Research Consortium [VARC]-defined)

    Time frame: during hospitalization approximatively 3 days

    TAVR Device Success evaluated post-procedure/pre-discharge during hospitalization approximatively 3 days, defined as: absence of procedural mortality AND correct positioning of a single prosthetic heart valve into the proper anatomical location AND intended performance of the prosthetic heart valve (defined as no prosthesis-patient mismatch [VARC-defined] and mean aortic valve gradient <20 mm Hg or peak velocity <3 m/s, AND no moderate or severe prosthetic valve regurgitation [VARC-defined] [site and Core Laboratory-reported].

  26. Composite Safety Endpoints (VARC-3 defined)

    Time frame: 30 days and 12 months post-TAVR

    Composite safety endpoint reported as a proportion of participants who died or experienced neurological events or life-threatening bleeding or acute kidney injury or coronary artery obstruction requiring intervention or major vascular complications or valve-related dysfunction requiring repeat procedure evaluated at 30 days and 12 months.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • Anteris Technologies Corporation

Registry information

Official study title

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

Acronym: DEFINE-TAVR

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Oct 5, 2022
Registry last updated
Aug 11, 2025

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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