INSPIRIS RESILIA Valve in Pulmonary Position
NCT05583656 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 40
Last updated 2022-10-18
Summary
In this trial we intend to evaluate the safety and effectiveness of the INSPIRIS valve prothesis in the pulmonary position in patients of five years or older, with congenital or acquired pulmonary valve disease, requiring replacement of their native or prosthetic pulmonary valve.
Conditions
- Pulmonary Valve Disorder
- Congenital Heart Disease
Interventions
- PROCEDURE
-
Pulmonary valve replacement
Surgical replacement of the pulmonary valve using the Edwards Inspiris Resilia prosthesis.
Sponsors & Collaborators
-
Medical University of Vienna
lead OTHER
Eligibility
- Min Age
- 5 Years
- Max Age
- 99 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-08-12
- Primary Completion
- 2023-08-01
- Completion
- 2024-02-01
Countries
- Austria
Study Locations
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