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Added Value of Patient-specific Computer Simulation in Transcatheter Aortic Valve Implantation (TAVI)

NCT03196596 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2019-02-06

No results posted yet for this study

Summary

Transcatheter aortic valve implantation is increasingly used to treat patients with severe aortic stenosis who are at increased risk for surgical aortic valve replacement and is projected to be the preferred treatment modality. As patient selection and operator experience have improved, it is hypothesised that device-host interactions will play a more dominant role in outcome. This, in combination with the increasing number of valve types and sizes, confronts the physician with the dilemma to choose the valve that best fits the individual patient. This necessitates the availability of pre-procedural computer simulation that is based upon the integration of the patient-specific anatomy, the physical and (bio)mechanical properties of the valve and recipient anatomy derived from in-vitro experiments. Patient-specific computer simulation may improve outcome of TAVI by proposing the valve size that best fits the individual patient.

The aim of this study is to assess the added value of patient-specific computer simulation in valve size selection.

Conditions

  • Aortic Valve Stenosis

Interventions

OTHER

Computer simulation

In these patients, a computer simulation model will be obtained based on pre procedural CT

Sponsors & Collaborators

Principal Investigators

  • Peter PT de Jaegere, MD, PhD · Erasmus Medical Center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-23
Primary Completion
2019-01-08
Completion
2019-01-31

Countries

  • Belgium
  • Denmark
  • Germany
  • Italy
  • Netherlands

Study Locations

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Entities

Companies

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 NCT03196596 on ClinicalTrials.gov