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Study identifier: NCT05788770 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

Preoperative CT-imaging with Patient-specific Computer Simulation in Transcatheter Aortic Valve Replacement

Condition: Aortic Valve Stenosis  ·  Sponsor: Romy Hegeman

PhaseNA
Planned participants454
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Romy Hegeman, MD  ·  +31 (0)6 41 71 16 79  ·  r.hegeman@antoniusziekenhuis.nl

Dirk-Jan van Ginkel, MD  ·  +31 (0) 88 320 66 48  ·  d.van.ginkel@antoniusziekenhuis.nl

Always discuss trial participation with your own doctor first.

Locations (2)

Vienna General HospitalVienna, AustriaRecruiting
St. Antonius HospitalNieuwegein, Utrecht, NetherlandsRecruiting

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Source record: clinicaltrials.gov/study/NCT05788770