Evaluation of the native aortic root pre-procedure and prosthesis geometry post implantation by MSCT to guide prosthesis size selection before percutaneous aortic valve replacement

Recruiting

• Conditions: artificial aortic valve; 10046973

• Registration Number: NL-OMON33154
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 150

Inclusion Criteria

Patient scheduled for percutaneous Aortic valve replacement

Exclusion Criteria

- Severe allergy to radiocontrast (previous anaphylaxis/angio-oedema)
- Severely irregular heart rhythm precluding diagnostic MSCT images
- Inability to breath hold for the duration of an MSCT scan
- Patients with severe renal impairment (estimated GFR below 20ml/min) will not be eligible for MSCT with contrast

Study & Design

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

Primary Outcome Measures

Name	Time	Method
<p>To determine which dimensions of the aortic root are optimal to guide<br /><br>prosthesis size selection</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- The quantitative and qualitative assessment of the geometry and degree of<br /><br>deformation of the PAVR prostheses with MSCT<br /><br>- To investigate the association between aortic regurgitation (valvular and<br /><br>para-valvular) post PAVR and 1) prosthesis sizing (degree of expansion,<br /><br>asymmetry and apposition) and 2) position (depth of implantation)</p><br>