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NCT Number: NCT05788770

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

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.

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Key information

Conditions

Aortic Valve Stenosis Aortic Valve Disease Cardiovascular Diseases Heart Diseases Heart Valve Diseases Ventricular Outflow Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vienna General Hospital, Vienna, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FEops HEARTGuide

Other

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 outcomes

  1. Mild to severe paravalvular regurgitation

    Time frame: 30-days

Secondary outcomes

  1. Incidence of new conduction disorder (new-onset left bundle branch block or new-onset atrioventricular block)

    Time frame: 30 days after TAVI

  2. Need for permanent pacemaker implantation

    Time frame: 30 days after TAVI

  3. Preoperative valve size selection

    Time frame: Preprocedural

  4. Final valve size

    Time frame: Perprocedural

  5. Target implantation depth

    Time frame: Preprocedural

  6. Final implantation depth

    Time frame: Perprocedural

  7. Change of preoperative decision in choice of default transcather heart valve

    Time frame: Preprocedural

  8. Change of preoperative decision in valve size selection

    Time frame: Preprocedural

  9. Change of preoperative decision in target implantation depth

    Time frame: Preprocedural

  10. Failure to implant valve

    Time frame: Preprocedural

  11. Composite endpoint of major adverse cardiac and cerebrovascular events (MACCE)

    Time frame: 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

  12. Quality of life assessed by the EuroQol questionnaire

    Time frame: 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.

  13. Quality of life assessed by the Kansas City Cardiomyopathy Questionnaire

    Time frame: 90 days after TAVI

    All scores are represented on a 0-to-100-point scale. Higher score refers to preferabel outcomes.

Study contacts

Contact information is provided by the study sponsor or research team.

Dirk-Jan van Ginkel, MD

CONTACT

[email protected]

+31 (0) 88 320 66 48

Romy Hegeman, MD

CONTACT

[email protected]

+31 (0)6 41 71 16 79

Sponsors and collaborators

Lead sponsor

Romy Hegeman

Other

Collaborators

  • ZonMw: The Netherlands Organisation for Health Research and Development

Registry information

Official study title

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

Acronym: GUIDE-TAVI

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Mar 29, 2023
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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