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Preoperative CT-imaging with Patient-specific Computer Simulation in Transcatheter Aortic Valve Replacement
Sponsor: Romy Hegeman
Summary
Combining routine preoperative CT imaging with patient-specific computer modelling predicts the interaction between different sizes of transcatheter aortic valve replacement devices at different implantation depths and the patient's unique anatomy (including post-implantation deformation) allowing preoperative evaluation of the risk for paravalvular leakage and conduction disorders. The objective of this randomized controlled trial is to evaluate whether pre-operative CT-imaging with advanced computer modelling and simulation (FEops HEARTguide™) adequately predicts procedural outcomes in TAVR procedures, whether it leads to changes of preoperative decisions and whether or not this leads to improved outcome in TAVR procedures.
Official title: Preoperative CT-imaging with Patient-specific Computer Simulation in Transcatheter Aortic Valve Replacement: a Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
454
Start Date
2022-04-06
Completion Date
2024-12-31
Last Updated
2024-09-19
Healthy Volunteers
No
Conditions
Interventions
FEops HEARTGuide
FEops HEARTGuide added to routine preoperative CT imaging. Results of the computer modelling will be discussed with TAVR implanting team prior to and during the procedure.
Locations (2)
Vienna General Hospital
Vienna, Austria
St. Antonius Hospital
Nieuwegein, Utrecht, Netherlands