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

Study Overview
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Brief Summary
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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.

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

Conditions
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Aortic Valve Stenosis

Intervention / Treatment
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* Other: FEops HEARTGuide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Multicenter, multinational, randomized controlled, open-label, trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FEops HEARTGuided transcatheter aortic valve implantation<br> | Other: FEops HEARTGuide<br>* 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.<br>|
| No Intervention: Standard transcatheter aortic valve implantation (no FEops HEARTGuide)<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mild to severe paravalvular regurgitation |  | 30-days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of new conduction disorder (new-onset left bundle branch block or new-onset atrioventricular block) |  | 30 days after TAVI | 
| 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 | 
| Change of preoperative decision in valve size selection |  | Preprocedural | 
| Change of preoperative decision in target implantation depth |  | Preprocedural | 
| Failure to implant valve |  | Preprocedural | 
| Composite endpoint of major adverse cardiac and cerebrovascular events (MACCE) | Including mortality, stroke, life-threatening bleeding, major vascular complications, valve-related dysfunction requiring repeat procedure (TAVR or SAVR), according to the VARC-3 criteria | 30 days after TAVI | 
| Quality of life assessed by the EuroQol-5 Dimension questionnaire |  | 90 days after TAVI | 
| Quality of life assessed by the Kansas City Cardiomyopathy Questionnaire |  | 90 days after TAVI |