Added Value of Patient-specific Computer Simulation in Transcatheter Aortic Valve Implantation (TAVI)
NCT ID: NCT03196596
Last Updated: 2019-02-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
80 participants
OBSERVATIONAL
2017-05-23
2019-01-31
Brief Summary
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The aim of this study is to assess the added value of patient-specific computer simulation in valve size selection.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Computer simulation
Patients in whom a computer simulation model will be obtained based on pre procedural CT
Computer simulation
In these patients, a computer simulation model will be obtained based on pre procedural CT
Prospective compare group
Patients in whom no computer simulation model will be obtained
No interventions assigned to this group
Interventions
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Computer simulation
In these patients, a computer simulation model will be obtained based on pre procedural CT
Eligibility Criteria
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Inclusion Criteria
* Planned for TAVI with the Evolut R Valve
Exclusion Criteria
* Extensive subannular calcifications
* Non-transfemoral access
* Poor CT quality
* Lack of written informed consent
18 Years
ALL
No
Sponsors
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Feops
INDUSTRY
Cardialysis B.V.
INDUSTRY
Erasmus Medical Center
OTHER
Responsible Party
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P de Jaegere
MD, PhD, Professor
Principal Investigators
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Peter PT de Jaegere, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Erasmus Medical Center
Locations
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Universitair Ziekenhuis Antwerpen
Edegem, , Belgium
Rigshospitalet
Copenhagen, , Denmark
University Hospital Cologne-Heart Center
Cologne, , Germany
Ospedale di San Raffaele
Milan, , Italy
Erasmus Medical Center
Rotterdam, South Holland, Netherlands
Countries
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References
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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.
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.
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.
Other Identifiers
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TAVIguide
Identifier Type: -
Identifier Source: org_study_id
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