Valve Plane Tracking for TAVI; Automatic Valve plane tracking for Transcatheter Aortic Valve Implantation.

Withdrawn

• Conditions: Aortic stenosis; Aorticvalve stenosis; 10046973

• Registration Number: NL-OMON40644
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

1. Subject is * 18 years of age.
2. Subject is eligible for TAVI with a a CE approved transcatheter heart valve.
3. Subject understands the study requirements and the treatment procedures, and provides written informed consent.
4. Subject is capable of returning to the study hospital for all required follow-up.

Exclusion Criteria

1. The aortic root cannot be defined by the software.
2. Subject did not receive a valve because of aborted procedure.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
<p>- Volume of contrast.<br /><br>- Valve deployment time.<br /><br>- Depth of implantation of the valve (non-coronary and left aortic sinus) in mm<br /><br>based upon contrast angiography after valve deployment.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Mortality within the hospital or at 30 days whichever comes first.<br /><br>- Renal insufficiency.<br /><br>- Paravalvular aortic regurgitation.</p><br>