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Recruiting NCT05788770

Preoperative CT-imaging with Patient-specific Computer Simulation in Transcatheter Aortic Valve Replacement

No phase Interventional Aortic Valve Stenosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: FEops HEARTGuide.
Who it may be relevant to
Registry conditions: Aortic Valve Stenosis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Austria, Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • Other FEops 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.

Primary outcome measures

  • Mild to severe paravalvular regurgitation [Time frame: 30-days]
Secondary outcome measures (12)
  • Incidence of new conduction disorder (new-onset left bundle branch block or new-onset atrioventricular block) [Time frame: 30 days after TAVI]
  • Need for permanent pacemaker implantation [Time frame: 30 days after TAVI]
  • Preoperative valve size selection [Time frame: Preprocedural]
  • Final valve size [Time frame: Perprocedural]
  • Target implantation depth [Time frame: Preprocedural]
  • Final implantation depth [Time frame: Perprocedural]
  • Change of preoperative decision in choice of default transcather heart valve [Time frame: Preprocedural]
  • Change of preoperative decision in valve size selection [Time frame: Preprocedural]
  • Change of preoperative decision in target implantation depth [Time frame: Preprocedural]
  • Failure to implant valve [Time frame: Preprocedural]
  • Composite endpoint of major adverse cardiac and cerebrovascular events (MACCE) [Time frame: 30 days after TAVI]
  • Quality of life assessed by the EuroQol questionnaire [Time frame: 90 days after TAVI]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Austria · 1 center
  • Vienna General Hospital — Vienna
Netherlands · 1 center
  • St. Antonius Hospital — Nieuwegein

Identifiers

NCT: NCT05788770 · NL77697.100.21

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗