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

NCT05788770 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 454

Last updated 2024-09-19

No results posted yet for this 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.

Conditions

  • Aortic Valve Stenosis

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.

Sponsors & Collaborators

  • ZonMw: The Netherlands Organisation for Health Research and Development

    collaborator OTHER

  • Romy Hegeman

    lead OTHER

Principal Investigators

  • Patrick Klein, MD, PhD · St. Antonius Hospital

  • Martin Swaans, MD, PhD · St. Antonius Hospital

  • Prof. Jurriën ten Berg, MD, PhD · St. Antonius Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-06
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • Austria
  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05788770 on ClinicalTrials.gov