Status:
UNKNOWN
Outcomes of Pulmonary Valve Replacement With the INSPIRIS (Model 11500A) Valve
Lead Sponsor:
Baylor College of Medicine
Collaborating Sponsors:
Edwards Lifesciences
Conditions:
Heart Valve Prosthesis
Eligibility:
All Genders
Up to 64 years
Brief Summary
The goal of this retrospective chart review is to contribute to the literature on the mid-term durability and hemodynamics of the INSPIRS Resilia bioprosthesis when implanted in children and young adu...
Detailed Description
The primary objective of our study is to contribute to the scarce body of literature on the mid-term durability and hemodynamics of the INSPIRIS Resilia (model 11500) bioprosthesis when implanted in t...
Eligibility Criteria
Inclusion
- Subjects that have received the INSPIRIS Resilia device at participating institutions from 06/2017 through 12/2022.
Exclusion
- Subjects that have not received the INSPIRIS Resilia device.
Key Trial Info
Start Date :
January 3 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05986396
Start Date
January 3 2023
End Date
December 31 2025
Last Update
August 14 2023
Active Locations (1)
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1
Baylor College of Medicine at CHRISTUS Children's
San Antonio, Texas, United States, 78207