Preoperative CT-imaging with Patient-specific Computer Simulation in Transcatheter Aortic
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 evaluati
| Condition(s) | Aortic Valve Stenosis |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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. |
| Who can participate | Inclusion Criteria: * Primary symptomatic severe aortic valve stenosis * Accepted for TAVR, either by transfemoral, transsubclavian or transapical access * Plan to implant one of the following transcatheter heart valves for which FEops HEARTguide™ is available (CoreValve™ Evolut™ R, and Evolut™ PRO and Evolut™ PRO+ (Medtronic, Minnesota, USA), ACURATE neo™ and ACURATE neo 2™ (Boston Scientific, Marlborough, MA, USA) * Informed consent Exclusion Criteria:a potential subject who meets any of the following criteria will be excluded from participation in this study before randomization: * Previous surgical aortic valve replacement * Permanent pacemaker at baseline * Emergency procedure * Poor CT image quality (disabling computer-simulation, i.e. generation of 3D anatomical models will not be p |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Romy Hegeman |
| Locations | Vienna, Austria; Nieuwegein, Utrecht, Netherlands |
| Start date | 2022-04-06 |
| NCT ID | NCT05788770 |
| Official listing | https://clinicaltrials.gov/study/NCT05788770 |