Preoperative CT-imaging with patient-specific computer simulation in transcatheter aortic valve replacement: a randomized controlled trial.

Recruiting

Conditions: aortic valve stenosis
10046973

Registration Number: NL-OMON56189

Lead Sponsor: Sint Antonius Ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 354

Inclusion Criteria

- Primary symptomatic severe aortic valve stenosis (defined as an aortic valve
area of <1.0cm2 and either a mean valve gradient of at least 40mmHg or a peak
velocity of at least 4.0 m/s)
- Accepted for TAVR, either by transfemoral, transsubclavian or transapical
access as determined by the Heart Team and additionally the dedicated TAVR-team.
- Plan to implant one of the following TAVR heart valves for which FEops
HEARTguide* is available:
o CoreValve*, Evolut* R, and Evolut* PRO and Evolut* PRO+ valves (Medtronic)
o ACURATE neo* Aortic Valve System (Boston Scientific) (ACURATE neo 2* will be
available for FHG later this year)
- Informed consent

Exclusion Criteria

- Previous surgical aortic valve replacement
- Permanent pacemaker at baseline
- Emergency procedure
- Poor CT image quality (disabling computer-simulation), for example because of
motion artifacts due to the presence of other implanted devices affecting the
region of interest
- Patient who did not agree to the informed consent and/or refused to
participate
- Patient unable to understand the informed consent/study

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Mild to severe PVR</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>New CD (new-onset left bundle branch block, new-onset atrioventricular block)<br /><br>requiring permanent pacemaker (PPM) implantation.<br /><br>Preoperative and final selected valve size, target and final implantation<br /><br>depth, change of preoperative decision, failure to implant valve, MACCE<br /><br>composite endpoint, quality of life, healthcare costs and cost-effectiveness,<br /><br>FFR measurement (on standard MSCT and CAG). </p><br>