Clinical trial NCT03196596: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Valve Stenosis
Keywords: TAVI
Computer simulation
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
Collaborators: name: Feops
name: Cardialysis B.V.
First posted: 2017-06-23
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with native severe aortic valve stenosis accepted for TAVI with the self-expanding Evolut R Valve by the local heart team

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.


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

Primary outcomes:
measure: Decision 1- Valve size decision based on pre TAVI MSCT
timeFrame: an average of 2 days before TAVI, before TAVI and computer simulation
measure: Decision 2- Valve size decision after knowledge of the computer simulation results
timeFrame: an average of 1 day before TAVI, before TAVI but after computer simulation
Secondary outcomes:
measure: Decision 3- Change of initial valve size decision during TAVI
timeFrame: an average of 5 minutes after TAVI, directly after TAVI
measure: Decision 3- Change of initial depth of implantation strategy during TAVI
timeFrame: an average of 5 minutes after TAVI, directly after TAVI
measure: Depth of implantation target
timeFrame: an average of 2 days before TAVI, before TAVI and computer simulation
measure: Depth of implantation target 2
timeFrame: an average of 1 day before TAVI, before TAVI but after computer simulation
measure: Aortic regurgitation
timeFrame: an average of 4 days after TAVI, at hospital discharge
measure: Correlation between predicted contact pressure and observed new conduction abnormality
timeFrame: an average of 4 days after TAVI, at hospital discharge
measure: MACCE
timeFrame: an average of 4 days after TAVI, at hospital discharge
measure: Incidence of the aforementioned outcome measures in a prospective group in whom no computer simulation will be perfomed
timeFrame: an average of 4 days after TAVI, at hospital discharge
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: Universitair Ziekenhuis Antwerpen
city: København
country: Denmark
facility: Rigshospitalet
city: Cologne
country: Germany
facility: University Hospital Cologne-Heart Center
city: Milano
country: Italy
facility: Ospedale di San Raffaele
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
state: Zuid-Holland
Study officials:
affiliation: Erasmus Medical Center
name: Peter PT de Jaegere, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schultz C, Rodriguez-Olivares R, Bosmans J, Lefevre T, De Santis G, Bruining N, Collas V, Dezutter T, Bosmans B, Rahhab Z, El Faquir N, Watanabe Y, Segers P, Verhegghe B, Chevalier B, van Mieghem N, De Beule M, Mortier P, de Jaegere P. Patient-specific image-based computer simulation for theprediction of valve morphology and calcium displacement after TAVI with the Medtronic CoreValve and the Edwards SAPIEN valve. EuroIntervention. 2016 Jan 22;11(9):1044-52. doi: 10.4244/EIJV11I9A212.
citation: de Jaegere P, De Santis G, Rodriguez-Olivares R, Bosmans J, Bruining N, Dezutter T, Rahhab Z, El Faquir N, Collas V, Bosmans B, Verhegghe B, Ren C, Geleinse M, Schultz C, van Mieghem N, De Beule M, Mortier P. Patient-Specific Computer Modeling to Predict Aortic Regurgitation After Transcatheter Aortic Valve Replacement. JACC Cardiovasc Interv. 2016 Mar 14;9(5):508-12. doi: 10.1016/j.jcin.2016.01.003. No abstract available.
citation: El Faquir N, Ren B, Van Mieghem NM, Bosmans J, de Jaegere PP. Patient-specific computer modelling - its role in the planning of transcatheter aortic valve implantation. Neth Heart J. 2017 Feb;25(2):100-105. doi: 10.1007/s12471-016-0923-6.