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

Last updated: September 17, 2024
Sponsor: Romy Hegeman
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

FEops HEARTGuide

Clinical Study ID

NCT05788770
NL77697.100.21
  • Ages > 18
  • All Genders

Study 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

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 FEopsHEARTguide™ 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

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 3Danatomical models will not be possible with poor CT image quality), for examplebecause of motion artifacts due to the presence of other implanted devices affectingthe 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

Total Participants: 454
Treatment Group(s): 1
Primary Treatment: FEops HEARTGuide
Phase:
Study Start date:
April 06, 2022
Estimated Completion Date:
December 31, 2024

Connect with a study center

  • Vienna General Hospital

    Vienna,
    Austria

    Active - Recruiting

  • St. Antonius Hospital

    Nieuwegein, Utrecht 3435 CM
    Netherlands

    Active - Recruiting

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