Preoperative CT-imaging With Patient-specific Computer Simulation in Transcatheter Aortic Valve Replacement: a Randomized Controlled Trial - Trial NCT05788770
Access comprehensive clinical trial information for NCT05788770 through Pure Global AI's free database. This phase not specified trial is sponsored by Romy Hegeman and is currently Recruiting. The study focuses on Aortic Valve Stenosis. Target enrollment is 454 participants.
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Study Focus
Sponsor & Location
Romy Hegeman
St. Antonius Hospital
Timeline & Enrollment
N/A
Apr 06, 2022
Dec 31, 2024
Primary Outcome
Mild to severe paravalvular regurgitation
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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT05788770
Non-Device Trial