Clinical trial NCT05567809: Defining Exercise Hemodynamics and Function After Transcatheter Aortic Valve Replacement (DEFINE-TAVR) Study.
Official title: DEFINE-TAVR (Defining Exercise Hemodynamics and Function After Transcatheter Aortic Valve Replacement) Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Valve Stenosis
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Anteris Technologies Corporation
First posted: 2022-10-05
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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.

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

Primary outcomes:
measure: TransAortic Valve Gradient during exercise at 30 days post-TAVR
timeFrame: 30 days post-TAVR
Secondary outcomes:
measure: Change in valve cusp thickness at rest
timeFrame: baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR
measure: Change in valve mobility at rest
timeFrame: baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR
measure: Change in paravalvular leak at rest
timeFrame: baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR
measure: Change in coefficient of contraction Effective Orifice Area (EOA)/Geometric Orifice Area (GOA) at rest
timeFrame: baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR
measure: Change in Dimensionless Velocity Index (DVI) at rest
timeFrame: baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR
measure: Change in energy loss coefficient at rest
timeFrame: baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR
measure: Change in EOA at rest
timeFrame: baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR
measure: Change in aortic valve gradient (peak and mean) at rest
timeFrame: baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR
measure: Change in aortic valve velocity (peak and mean) at rest
timeFrame: baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR
measure: Change in Left Ventricle (LV) remodeling at rest
timeFrame: baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR
measure: Change in leaflet thickening at rest
timeFrame: baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR
measure: Change in coaptation length at rest
timeFrame: baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR
measure: Change in LV thickness at rest
timeFrame: baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR
measure: Change in LV Global Longitudinal Strain at rest
timeFrame: baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR
measure: Change in Right Ventricular (RV) systolic velocity at rest
timeFrame: baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR
measure: Change in RV systolic pressure (RVSP) at rest
timeFrame: baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR
measure: Change in Tricuspid Annular Plane Systolic Excursion (TAPSE) at rest
timeFrame: baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR
measure: Change in aortic valve gradient (peak and mean) with exercise
timeFrame: 30 days, and 12 months post-TAVR
measure: Change in aortic valve velocity (peak and mean) with exercise
timeFrame: 30 days and 12 months post-TAVR
measure: Change in DVI with exercise
timeFrame: 30 days and 12 months post-TAVR
measure: Change in EOA with exercise
timeFrame: 30 days and 12 months post-TAVR
measure: Change in RVSP with exercise
timeFrame: 30 days and 12 months post-TAVR
measure: Change in exercise duration
timeFrame: 30 days and 12 months post-TAVR
measure: Change in LV Global Longitudinal Strain with exercise
timeFrame: 30 days and 12 months post-TAVR
measure: TAVR Device Success (Valve Academic Research Consortium [VARC]-defined)
timeFrame: during hospitalization approximatively 3 days
measure: Composite Safety Endpoints (VARC-3 defined)
timeFrame: 30 days and 12 months post-TAVR
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
Study officials:
affiliation: Yale University
name: Amit Vora, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Yale University
name: Alexandra J Lansky, MD
role: STUDY_CHAIR
References: