Brief Title
Added Value of Patient-specific Computer Simulation in Transcatheter Aortic Valve Implantation (TAVI)
Official Title
The Value of Patient-specific Computer Simulation in the Planning of TAVI With the Self-expanding Evolut R Valve
Brief 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.
Study Type
Observational
Primary Outcome
Decision 1- Valve size decision based on pre TAVI MSCT
Secondary Outcome
Decision 3- Change of initial valve size decision during TAVI
Condition
Aortic Valve Stenosis
Intervention
Computer simulation
Study Arms / Comparison Groups
Computer simulation
Description: Patients in whom a computer simulation model will be obtained based on pre procedural CT
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
80
Start Date
May 23, 2017
Completion Date
January 31, 2019
Primary Completion Date
January 8, 2019
Eligibility Criteria
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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Peter PT de Jaegere, MD, PhD, ,
Location Countries
Belgium
Location Countries
Belgium
Administrative Informations
NCT ID
NCT03196596
Organization ID
TAVIguide
Responsible Party
Principal Investigator
Study Sponsor
Erasmus Medical Center
Collaborators
feops
Study Sponsor
Peter PT de Jaegere, MD, PhD, Principal Investigator, Erasmus Medical Center
Verification Date
February 2019