I see the YALE University Study -
"Defining Exercise Hemodynamics and Function After Transcatheter Aortic Valve Replacement (DEFINE-TAVR) Study. (DEFINE-TAVR)"
is currently recruiting!
Anteris is the Sponsor/Collaborator with Yale University for this study.
Principal Investigator: Yousif Ahmad, MD,Yale University
The study doesn't mention DurAVR but we know it must be as they are the sponsor!
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
escribe 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.
Primary Outcome Measure = 1
Secondary Outcome Measures = 26
The PRIMARY COMPLETION (ESTIMATED) dated May 2023 and a STUDY COMPLETION (ESTIMATED) dated Oct 2023.
Looks like another 50+ DurAVR implants to happen in the next few months(recruiting between 50 -100 volunteers) , one of the Study Patient Exclusion Criteria is Previously implanted prosthetic aortic valve (i.e., planned valve-in-valve TAVR). As the study is also comparing self-expanding and balloon expandable valves I'm guessing Yale will also use Medtronic's CoreValve.
Could be exciting results mid to late this year when coupled with the EFS trial which will be well and truly underway.
More information can be found at
https://beta.clinicaltrials.gov/study/NCT05567809
