NCT05788770

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

Preoperative CT-imaging with Patient-specific Computer Simulation in Transcatheter Aortic Valve Replacement: a Randomized Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 454 (estimated)
• Sponsor: Romy Hegeman · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Aortic Valve Stenosis

Interventions

Type	Name	Description
OTHER	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.

Timeline

• Start date: 2022-04-06
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2023-03-29
• Last updated: 2024-09-19

Locations

2 sites across 2 countries: Austria, Netherlands