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

NCT05567809 | Completed

• 2 other identifiers: 2000033211YSI-002
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Aortic Valve Stenosis

Outcome Measures

Primary Outcomes (1)

• TransAortic Valve Gradient during exercise at 12 months post-TAVR

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

  12 months post-TAVR

Secondary Outcomes (26)

• Change in valve cusp thickness 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 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 Dimensionless Velocity Index (DVI) at rest

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead
• Anteris Technologies Corporation: collaborator

Study Sites (1)

Yale New Haven Hospital

New Haven, Connecticut, 06510, United States

Location

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Amit Vora, MD

  Yale University

  PRINCIPAL INVESTIGATOR

• Alexandra J Lansky, MD

  Yale University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2022
• First Posted: October 5, 2022
• Study Start: October 25, 2022
• Primary Completion: January 21, 2025
• Study Completion: January 21, 2025
• Last Updated: August 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)