Aortic Valve Stenosis
Conditions
Brief 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.
Interventions
OTHERFEops 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.
Sponsors
ZonMw: The Netherlands Organisation for Health Research and Development
Romy Hegeman
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Multicenter, multinational, randomized controlled, open-label, trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mild to severe paravalvular regurgitation | 30-days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Need for permanent pacemaker implantation | 30 days after TAVI | — |
| Preoperative valve size selection | Preprocedural | — |
| Final valve size | Perprocedural | — |
| Target implantation depth | Preprocedural | — |
| Final implantation depth | Perprocedural | — |
| Change of preoperative decision in choice of default transcather heart valve | Preprocedural | — |
| Incidence of new conduction disorder (new-onset left bundle branch block or new-onset atrioventricular block) | 30 days after TAVI | — |
| Change of preoperative decision in target implantation depth | Preprocedural | — |
| Failure to implant valve | Preprocedural | — |
| Composite endpoint of major adverse cardiac and cerebrovascular events (MACCE) | 30 days after TAVI | Including mortality, stroke, life-threatening bleeding, major vascular complications, valve-related dysfunction requiring repeat procedure (TAVR or SAVR), according to the VARC-3 criteria |
| Quality of life assessed by the EuroQol questionnaire | 90 days after TAVI | EuroQol-5 Dimensions-5 Levels, lower levels refer to better outcomes. Visual analog scale (0-100). Higher scores refer to a better outcome. |
| Quality of life assessed by the Kansas City Cardiomyopathy Questionnaire | 90 days after TAVI | All scores are represented on a 0-to-100-point scale. Higher score refers to preferabel outcomes. |
| Change of preoperative decision in valve size selection | Preprocedural | — |
Countries
Austria, Netherlands
Contacts
Primary ContactRomy Hegeman, MD
Backup ContactDirk-Jan van Ginkel, MD
Outcome results
None listed