COmparison of iN situ structural integrity of TrAnsCatheter Heart Valves

• Conditions: function and durability of aorticvalve; Structural integrity of transcatheter heart valve; 10046973

• Registration Number: NL-OMON40932
• 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: Pending
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

All Patients who undergo TAVI with the following THV are eligible for this study:
1. Medtronic Corevalve
2. Edwards Sapien and Sapien 3
3. BSC Lotus
4. St Jude Portico
5. Jenavalve THV
6. Direct Flow

Exclusion Criteria

Exclusion criteria
1) GFR < 40 mL/min
2) No written informed consent
3) Previous stroke with residual neurological symptoms or dementia
4) Not native Dutch speaking

Study & Design

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

Primary Outcome Measures

Name	Time	Method
<p>Primary Objective: MSCT and rotational angiography protocol is used to assess:<br /><br>o Identify fractures in the framework<br /><br>o Determine diameter of THV inflow, outflow and valve functioning segment and<br /><br>assess circularity<br /><br>o Determine Inflow and constraint segment perimeter and area<br /><br>o Aortic root -THV relationship: circularity index of aortic root and THV</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary Objective:<br /><br>o Transprosthetic gradient as assessed by Doppler TTE<br /><br>o (paravalvular) aortic regurgitation by Doppler TTE<br /><br>o Assess LV diameters/volumes</p><br>