Clinical trial NCT05788770: Preoperative CT-imaging with Patient-specific Computer Simulation in Transcatheter Aortic Valve Replacement
Official title: Preoperative CT-imaging with Patient-specific Computer Simulation in Transcatheter Aortic Valve Replacement: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Aortic Valve Stenosis
Lead sponsor: St. Antonius Hospital
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
First posted: 2023-03-29
Enrollment: 454
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multicenter, multinational, randomized controlled, open-label, trial
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Mild to severe paravalvular regurgitation
timeFrame: 30-days
Secondary outcomes:
measure: Incidence of new conduction disorder (new-onset left bundle branch block or new-onset atrioventricular block)
timeFrame: 30 days after TAVI
measure: Need for permanent pacemaker implantation
timeFrame: 30 days after TAVI
measure: Preoperative valve size selection
timeFrame: Preprocedural
measure: Final valve size
timeFrame: Perprocedural
measure: Target implantation depth
timeFrame: Preprocedural
measure: Final implantation depth
timeFrame: Perprocedural
measure: Change of preoperative decision in choice of default transcather heart valve
timeFrame: Preprocedural
measure: Change of preoperative decision in valve size selection
timeFrame: Preprocedural
measure: Change of preoperative decision in target implantation depth
timeFrame: Preprocedural
measure: Failure to implant valve
timeFrame: Preprocedural
measure: Composite endpoint of major adverse cardiac and cerebrovascular events (MACCE)
timeFrame: 30 days after TAVI
measure: Quality of life assessed by the EuroQol questionnaire
timeFrame: 90 days after TAVI
measure: Quality of life assessed by the Kansas City Cardiomyopathy Questionnaire
timeFrame: 90 days after TAVI
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Vienna General Hospital
city: Nieuwegein
country: Netherlands
facility: St. Antonius Hospital
state: Utrecht
Study officials:
affiliation: St. Antonius Hospital
name: Patrick Klein, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Antonius Hospital
name: Martin Swaans, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Antonius Hospital
name: Prof. Jurriën ten Berg, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: