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

Erasmus University

Status: Completed

Conditions: Aortic Valve Stenosis

Treatments: Other: Computer simulation

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03196596

TAVIguide

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Native severe aortic valve stenosis
• Planned for TAVI with the Evolut R Valve

Exclusion criteria

• Bicuspid aortic valve
• Extensive subannular calcifications
• Non-transfemoral access
• Poor CT quality
• Lack of written informed consent

Trial design

80 participants in 2 patient groups

Computer simulation

Description:

Patients in whom a computer simulation model will be obtained based on pre procedural CT

Treatment:

Other: Computer simulation

Prospective compare group

Description:

Patients in whom no computer simulation model will be obtained