aortic valve stenosis
Conditions
Interventions
In patients randomized to arm 1, FEops HEARTGuide will be added to routine
preoperative CT imaging. Results of the computer modelling will be discussed
with TAVR implanting team prior to the procedu
Sponsors
Sint Antonius Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Primary symptomatic severe aortic valve stenosis (defined as an aortic valve area of
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mild to severe PVR | — |
Secondary
| Measure | Time frame |
|---|---|
| New CD (new-onset left bundle branch block, new-onset atrioventricular block) requiring permanent pacemaker (PPM) implantation. Preoperative and final selected valve size, target and final implantation depth, change of preoperative decision, failure to implant valve, MACCE composite endpoint, quality of life, healthcare costs and cost-effectiveness, FFR measurement (on standard MSCT and CAG). | — |
Countries
Netherlands
Outcome results
None listed