Outcomes of Pulmonary Valve Replacement With the INSPIRIS (Model 11500A) Valve
NCT05986396 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 100
Last updated 2023-08-14
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 adults.
Conditions
- Heart Valve Prosthesis
Interventions
- DEVICE
-
INSPIRIS Resilia (model 11500A)
Aortic Valve
Sponsors & Collaborators
-
Edwards Lifesciences
collaborator INDUSTRY -
Baylor College of Medicine
lead OTHER
Principal Investigators
-
Victor Bautista-Hernandez, MD, PhD · Baylor College of Medicine
Eligibility
- Min Age
- 0 Years
- Max Age
- 64 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-01-03
- Primary Completion
- 2024-12-31
- Completion
- 2025-12-31
Countries
- United States
Study Locations
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