INVAsive, ultraSOUND and MRI assessment of transvalvular gradients after transcatheter aortic valve implantatio

• Conditions: bioprosthetic heart valve; TAVI; 10046973; 10007593

• Registration Number: NL-OMON56835
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 8 July 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 64

Inclusion Criteria

- Adult patient (>18 years)
- Post TAVI procedure
- Successful TAVI with no unresolved procedure related complications (VARC-3
definition)
o Successful access, delivery of the device, and retrieval of the delivery
system
o Correct positioning of a single prosthetic heart valve into the proper
anatomical location
o Freedom from surgery or intervention related to the device or to a major
vascular or access-related, or cardiac structural complication

Exclusion Criteria

- Age < 18 years
- Atrial fibrillation or atrial flutter or frequent extrasystole limiting the
quality of the cardiac MRI
- ICD or (temporary) pacemaker in situ
- Valve in valve procedure
- Claustrophobia
- Kidney injury (eGFR <30 mL/min per 1.73 m2)
- Gadolinium based contrast allergy
- No (written) informed consent was obtained

Study & Design

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

Primary Outcome Measures

Name	Time	Method
<p>The primary study endpoint is the transprosthetic aortic gradient by 4D flow<br /><br>MRI.</p><br>