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Clinical Trials/NCT05567809
NCT05567809CompletedNot Applicable

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

Yale University1 site in 1 country28 target enrollmentStarted: October 25, 2022Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
28
Locations
1
Primary Endpoint
TransAortic Valve Gradient during exercise at 12 months post-TAVR
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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

Detailed 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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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

  • Change in valve cusp thickness at rest(baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR)
  • Change in EOA at rest(baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR)
  • Change in valve mobility at rest(baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR)
  • Change in paravalvular leak at rest(baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR)
  • Change in energy loss coefficient at rest(baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR)
  • Change in aortic valve gradient (peak and mean) at rest(baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR)
  • Change in LV thickness at rest(baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR)
  • Change in LV Global Longitudinal Strain at rest(baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR)
  • Change in Right Ventricular (RV) systolic velocity at rest(baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR)
  • Change in aortic valve velocity (peak and mean) with exercise(30 days and 12 months post-TAVR)
  • Change in Dimensionless Velocity Index (DVI) at rest(baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR)
  • Change in aortic valve velocity (peak and mean) at rest(baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR)
  • Change in coaptation length at rest(baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR)
  • Change in RV systolic pressure (RVSP) at rest(baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR)
  • Change in aortic valve gradient (peak and mean) with exercise(30 days, and 12 months post-TAVR)
  • Change in DVI with exercise(30 days and 12 months post-TAVR)
  • Change in RVSP with exercise(30 days and 12 months post-TAVR)
  • Change in exercise duration(30 days and 12 months post-TAVR)
  • Change in Left Ventricle (LV) remodeling at rest(baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR)
  • Change in leaflet thickening at rest(baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR)
  • Change in LV Global Longitudinal Strain with exercise(30 days and 12 months post-TAVR)
  • Composite Safety Endpoints (VARC-3 defined)(30 days and 12 months post-TAVR)
  • TAVR Device Success (Valve Academic Research Consortium [VARC]-defined)(during hospitalization approximatively 3 days)
  • Change in coefficient of contraction Effective Orifice Area (EOA)/Geometric Orifice Area (GOA) at rest(baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR)
  • Change in Tricuspid Annular Plane Systolic Excursion (TAPSE) at rest(baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR)
  • Change in EOA with exercise(30 days and 12 months post-TAVR)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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