Detection of High Intensity Transient Signals after aortic valve replacement

Withdrawn

• Conditions: Neurocognitive Disorder; 10046973; 10007963

• Registration Number: NL-OMON30608
• Lead Sponsor: Catharina-ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

- All patients undergoing isolated aortic valve replacement
- Replacement for acquired aortic valve disease
- INR in therapeutic range when measuring HITS

Exclusion Criteria

- Concomitant procedures
- Congential lesions
- No sinus rhytm
- Carotic artery diseases
- History of cerebrovascular events (stroke as well as transient ischemic attack)
- Neurocognitive deficits and psychiatric disorder

Study & Design

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

Primary Outcome Measures

Name	Time	Method
<p>- Detection of HITS after aortic valve replacement with determination of the<br /><br>accuracy and precision of the diagnostic test. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Optimum orientation of mechanical valves<br /><br>- Origin and nature (pathogenesis)of HITS<br /><br>- Postoperative depravation of H.I.T.S.<br /><br>- Difference between HITS measurement in mechanical and biological valve<br /><br>prosthesis</p><br>