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

NCT ID: NCT05567809

Last Updated: 2025-08-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 28 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-10-25
• Study Completion Date: 2025-01-21

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.

Conditions

Aortic Valve Stenosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Anteris Technologies Corporation

UNKNOWN

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amit Vora, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Alexandra J Lansky, MD

Role: STUDY_CHAIR

Yale University

Locations

Yale New Haven Hospital

New Haven, Connecticut, United States

Countries

United States

Other Identifiers

YSI-002

Identifier Type: OTHER

Identifier Source: secondary_id

2000033211

Identifier Type: -

Identifier Source: org_study_id