Preoperative CT-imaging With Patient-specific Computer Simulation in Transcatheter Aortic Valve Replacement
- Conditions
- Aortic Valve Stenosis
- Interventions
- Other: FEops HEARTGuide
- Registration Number
- NCT05788770
- Lead Sponsor
- Romy Hegeman
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 454
- 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
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description FEops HEARTGuide FEops HEARTGuide Device selection using FEops HEARTGuide: 3D anatomical analysis and simulation of transcatheter aortic valve prosthesis prior to procedure based on computed tomography.
- Primary Outcome Measures
Name Time Method Mild to severe paravalvular regurgitation 30-days
- Secondary Outcome Measures
Name Time Method 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) 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.
Trial Locations
- Locations (2)
St. Antonius Hospital
🇳🇱Nieuwegein, Utrecht, Netherlands
Vienna General Hospital
🇦🇹Vienna, Austria