ong-Term Follow-Up of the Freestyle Stentless Bioprosthesis

Completed

• Conditions: aortic root pathology; Aortic valve pathology; 10046973

• Registration Number: NL-OMON40663
• Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 250

Inclusion Criteria

Implantation of the Freestyle bioprosthesis in the LUMC

Exclusion Criteria

Explantation of Freestyle bioprosthesis

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Structural valve detoriation</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Valve-related mortality<br /><br>Valve related events (nonstructural valve dysfunction, valve thrombosis,<br /><br>thromboembolism, hemorrhage, valve endocarditis)<br /><br>Hemodynamic performance (effective orifice area, peak transvalvular gradient,<br /><br>LV mass reduction)<br /><br>Quality of life (physical health, mental health)</p><br>