NCT03196596

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

The Value of Patient-specific Computer Simulation in the Planning of TAVI With the Self-expanding Evolut R Valve

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 80 (actual)
• Sponsor: Erasmus Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
OTHER	Computer simulation	In these patients, a computer simulation model will be obtained based on pre procedural CT

Timeline

• Start date: 2017-05-23
• Primary completion: 2019-01-08
• Completion: 2019-01-31
• First posted: 2017-06-23
• Last updated: 2019-02-06

Locations

5 sites across 5 countries: Belgium, Denmark, Germany, Italy, Netherlands