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Freestyle-Perimount Calcification Comparison

NCT04359030 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 90

Last updated 2024-07-24

No results posted yet for this study

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 stented bioprostheses (Perimount Magna Ease, PM). A 3D CT scan will be used to assess the calcification score and to determine the relationship between calcification and aortic valve leaflet.

Conditions

  • Aortic Valve Disease
  • Valve Heart Disease

Interventions

DIAGNOSTIC_TEST

Multislice CT scanning for aortic wall calcification

Multislice CT scanning for aortic wall calcification

DIAGNOSTIC_TEST

Transthoracic stress echocardiography

Transthoracic stress echocardiography

Sponsors & Collaborators

  • Universitaire Ziekenhuizen KU Leuven

    collaborator OTHER

  • Ziekenhuis Oost-Limburg

    lead OTHER

Principal Investigators

  • Matteo Pettinari · Ziekenhuis Oost-Limburg

Eligibility

Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-15
Primary Completion
2022-06-01
Completion
2022-10-01

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04359030 on ClinicalTrials.gov