Status:
SUSPENDED
INSPIRIS RESILIA Aortic Valve, Valve-in-Valve Surveillance Study
Lead Sponsor:
Edwards Lifesciences
Conditions:
Aortic Valve Replacement
Eligibility:
All Genders
18+ years
Brief Summary
The primary objective of the INSPIRIS RESILIA Aortic Valve-in-valve (ViV) Surveillance Study ("the Study") is to capture Adverse Event information and valve measurement data from dysfunctional INSPIRI...
Detailed Description
This is a single-arm observational study which includes both prospective and retrospective data. At least fifty (50) Subjects enrolled prospectively prior to the ViV procedure, or retrospectively aft...
Eligibility Criteria
Inclusion
- Subjects must meet all of the following
- 18 years or older at the time of the TAVR ViV treatment
- Has an INSPIRIS RESILIA aortic valve implanted in the aortic position confirmed to be size 19mm, 21mm, 23mm or 25mm
- A ViV procedure using an Edwards transcatheter aortic heart valve (TAVR) has been scheduled; or completed within 37 days from time of consent
- The participant agrees to attend a follow-up assessment at 1 month post ViV procedure
- The participant provides written informed consent prior to the post-ViV procedure CT scan
Exclusion
- Subjects must not meet any of the following
Key Trial Info
Start Date :
June 1 2028
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2031
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04902053
Start Date
June 1 2028
End Date
January 1 2031
Last Update
September 2 2025
Active Locations (7)
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1
University of Southern California
Los Angeles, California, United States, 90033
2
University of Florida
Gainesville, Florida, United States, 32611
3
AdventHealth Orlando
Orlando, Florida, United States, 32803
4
St. Vincent Hospital
Indianapolis, Indiana, United States, 46290