Status:
COMPLETED
Freestyle-Perimount Calcification Comparison
Lead Sponsor:
Ziekenhuis Oost-Limburg
Collaborating Sponsors:
Universitaire Ziekenhuizen KU Leuven
Conditions:
Aortic Valve Disease
Valve Heart Disease
Eligibility:
All Genders
Up to 60 years
Brief Summary
The aim of this study is to evaluate the rate and anatomy of the aortic wall and leaflet calcification of the FS prosthesis implanted as full root in patients younger than 60 years compared to a stent...
Detailed Description
A recent update of the American Hear Association and American College of Cardiology Guidelines for the Management of Patients With Valvular Heart Disease1 recommended that for patients between 50 and ...
Eligibility Criteria
Inclusion
- Provision of signed and dated informed consent form
- Patients treated with FS or PM
- Age less than 60 at the moment of the implant
Exclusion
- Kidney failure or contrast allergy
- Previous endocarditis and aortic dissection
- Pregnancy or lactation
Key Trial Info
Start Date :
November 15 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2022
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT04359030
Start Date
November 15 2021
End Date
October 1 2022
Last Update
July 24 2024
Active Locations (1)
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1
Ziekenhuis Oost Limburg
Genk, Limburg, Belgium, 3600