Added Value of Patient-specific Computer Simulation in Transcatheter Aortic Valve Implantation (TAVI)
- Conditions
- Aortic Valve Stenosis
- Interventions
- Other: Computer simulation
- Registration Number
- NCT03196596
- Lead Sponsor
- Erasmus Medical Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
- Native severe aortic valve stenosis
- Planned for TAVI with the Evolut R Valve
- Bicuspid aortic valve
- Extensive subannular calcifications
- Non-transfemoral access
- Poor CT quality
- Lack of written informed consent
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Computer simulation Computer simulation Patients in whom a computer simulation model will be obtained based on pre procedural CT
- Primary Outcome Measures
Name Time Method Decision 2- Valve size decision after knowledge of the computer simulation results an average of 1 day before TAVI, before TAVI but after computer simulation Valve size decision after availability of the results of computer simulation
Decision 1- Valve size decision based on pre TAVI MSCT an average of 2 days before TAVI, before TAVI and computer simulation Valve size decision based on pre TAVI Multislice Computed Tomography (MSCT), which is performed in all patients referred for TAVI in accordance to clinical routine, during the heart team meeting
- Secondary Outcome Measures
Name Time Method Depth of implantation target 2 an average of 1 day before TAVI, before TAVI but after computer simulation Depth of implantation strategy after availability of computer simulation
Correlation between predicted contact pressure and observed new conduction abnormality an average of 4 days after TAVI, at hospital discharge To compare the predicted maximum contact pressure, contact pressure index and conduction abnormalities with the observed occurrence of new conduction abnormalities after TAVI
Incidence of the aforementioned outcome measures in a prospective group in whom no computer simulation will be perfomed an average of 4 days after TAVI, at hospital discharge To compare the clinical based valve size decision and the angiographic and echocardiographic valve performance, depth of implantation, new conduction disorders and MACCE in a prospectively collected group of patients in whom no computer simulation will be performed
MACCE an average of 4 days after TAVI, at hospital discharge To assess the incidence of Major Adverse Cardiovascular and Cerebrovascular Event (MACCE)
Decision 3- Change of initial valve size decision during TAVI an average of 5 minutes after TAVI, directly after TAVI Change of valve size decision during TAVI due to computer simulation
Decision 3- Change of initial depth of implantation strategy during TAVI an average of 5 minutes after TAVI, directly after TAVI Change of depth of implantation strategy during TAVI due to computer simulation
Depth of implantation target an average of 2 days before TAVI, before TAVI and computer simulation Initial depth of implantation strategy
Aortic regurgitation an average of 4 days after TAVI, at hospital discharge To compare the predicted (simulation) and observed degree of aortic regurgitation (echo post TAVI - Valve Academic Research Consortium (VARC-2) criteria for aortic regurgitation)
Trial Locations
- Locations (5)
Universitair Ziekenhuis Antwerpen
🇧🇪Edegem, Belgium
Rigshospitalet
🇩🇰København, Denmark
University Hospital Cologne-Heart Center
🇩🇪Cologne, Germany
Ospedale di San Raffaele
🇮🇹Milano, Italy
Erasmus Medical Center
🇳🇱Rotterdam, Zuid-Holland, Netherlands