Freestyle-Perimount Calcification Comparison

NCT04359030 | Completed DMC

• 1 other identifier: ctu2020003
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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 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

Outcome Measures

Primary Outcomes (1)

• Quantification of aortic leaflet Calcium-score in FS and PM valve

  The Agatston score. The score is calculated using a weighted value assigned to the highest density of calcification in a given coronary artery. The density is measured in Hounsfield units (HU), and score of 1 for 130-199 HU, 2 for 200-299 HU, 3 for 300-399 HU, and 4 for 400 HU and greater. The higher the score the more the calcification.

  3 years

Secondary Outcomes (4)

• Echocardiographic function of the aortic valve at rest and during exercise: transvalvular mean and peak gradient

  3 years

• Echocardiographic function of the aortic valve at rest and during exercise: Valve regurgitation

  3 years

• Exercise capacity: New York Heart Association class

  3 years

• Exercise capacity: maximum oxygen consumption

  3 years

Study Arms (2)

Freestyle group

Patients treated with a Freestyle aortic valve bioprosthesis

Diagnostic Test: Multislice CT scanning for aortic wall calcification; Diagnostic Test: Transthoracic stress echocardiography

Perimount group

Patients treated with a Perimount aortic valve bioprosthesis

Diagnostic Test: Multislice CT scanning for aortic wall calcification; Diagnostic Test: Transthoracic stress echocardiography

Interventions

Multislice CT scanning for aortic wall calcification DIAGNOSTIC_TEST

Multislice CT scanning for aortic wall calcification

Freestyle group; Perimount group

Transthoracic stress echocardiography DIAGNOSTIC_TEST

Transthoracic stress echocardiography

Freestyle group; Perimount group

Eligibility Criteria

• Age: Up to 60 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients operated for aortic valve stenosis at least three years earlier undergoing a valve replacement with Freestyle (FS) or Perimount (PM) bioprosthesis under the age of 60 years.

You may qualify if:

• Provision of signed and dated informed consent form
• Patients treated with FS or PM
• Age less than 60 at the moment of the implant

You may not qualify if:

• Kidney failure or contrast allergy
• Previous endocarditis and aortic dissection
• Pregnancy or lactation

Sponsors & Collaborators

• Ziekenhuis Oost-Limburg: lead
• Universitaire Ziekenhuizen KU Leuven: collaborator

Study Sites (1)

Ziekenhuis Oost Limburg

Genk, Limburg, 3600, Belgium

Location

MeSH Terms

Conditions

Aortic Valve Disease; Heart Valve Diseases

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Matteo Pettinari

  Ziekenhuis Oost-Limburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 17, 2020
• First Posted: April 24, 2020
• Study Start: November 15, 2021
• Primary Completion: June 1, 2022
• Study Completion: October 1, 2022
• Last Updated: July 24, 2024

Record last verified: 2024-07

Locations

BE (1)