Preoperative CT-imaging With Patient-specific Computer Simulation in Transcatheter Aortic Valve Replacement: a Randomized Controlled Trial (GUIDE-TAVI)
Aortic Valve Stenosis
About this trial
This is an interventional treatment trial for Aortic Valve Stenosis
Eligibility Criteria
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 possible with poor CT image quality), for example because of motion artifacts due to the presence of other implanted devices affecting the region of interest Patient who did not agree to the informed consent and/or refused to participate Patient unable to understand the informed consent/study
Sites / Locations
- Vienna General Hospital
- St. Antonius HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
FEops HEARTGuided transcatheter aortic valve implantation
Standard transcatheter aortic valve implantation (no FEops HEARTGuide)