Addition of Computer Simulations to Minimize Adverse Events After Transcatheter Aortic Valve Implantation
NCT04473443 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 200
Last updated 2022-07-27
Summary
The objective is to assess the influence of FEops HEARTguide on overall device success in TAVI patients with challenging anatomies (Cohort A) or in transcatheter heart valve (THV) platform selection (Cohort B).
Conditions
- Aortic Valve Stenosis
- Bicuspid Cardiac Valve
Interventions
- OTHER
-
FEops HEARTguideTM
A patient-specific computer simulation that aims to improve the outcomes after TAVI by suggesting THV platform, THV size and implantation depth with the use of the pre-procedural CT-scan.
Sponsors & Collaborators
-
Feops
collaborator INDUSTRY - lead OTHER
Principal Investigators
-
Nicolas van Mieghem, Md,PhD · Erasmus Medical Center
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-08-01
- Primary Completion
- 2023-02-01
- Completion
- 2023-06-30
Countries
- Netherlands
Study Locations
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