Status:
WITHDRAWN
Targeted Testing for ATTR Among Aortic Stenosis Patients-Pilot
Lead Sponsor:
University of Texas Southwestern Medical Center
Collaborating Sponsors:
Mid America Heart Institute
Conditions:
Aortic Valve Stenosis
Cardiac Amyloidosis
Eligibility:
All Genders
75+ years
Phase:
NA
Brief Summary
Our ultimate goal is to design a multi-center randomized trial to test the hypothesis that targeted testing for transthyretin cardiac amyloid (ATTR) will improve survival and health status among aorti...
Detailed Description
Aim 1. To determine if an abnormal AVi value can identify ATTR among aortic stenosis patients undergoing TAVR. Patients undergoing TAVR for symptomatic severe aortic stenosis, with pre-TAVR echocardio...
Eligibility Criteria
Inclusion
- Successful implantation of a transcatheter heart valve with a commercially available valve (i.e. Sapien 3, Sapien Ultra, Evolut R, Evolut Pro, Evolut Pro+, or Lotus Edge) for native or bioprosthetic aortic stenosis
- Pre-implantation echocardiography with tissue Doppler imaging, if feasible
- Post-implantation invasive cardiac hemodynamics
Exclusion
- Age \<75 years
- Moderate to severe paravalvular aortic regurgitation on post-operative echocardiography
Key Trial Info
Start Date :
March 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04363294
Start Date
March 1 2022
End Date
August 1 2023
Last Update
March 23 2021
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