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NCT03196596: TAVIguide
Added Value of Patient-specific Computer Simulation in Transcatheter Aortic Valve Implantation (TAVI)
trial testing Computer simulation in Aortic Valve Stenosis in 80 participants. Completed in 31 January 2019.
8 January 2019
Quick facts
| Lead sponsor | Erasmus Medical Center |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 80 |
| Start date | 23 May 2017 |
| Primary completion | 8 January 2019 |
| Estimated completion | 31 January 2019 |
| Sites | 5 locations across Denmark, Italy, Netherlands, Belgium, Germany |
Drugs / interventions tested
- Computer simulation
Conditions studied
- Aortic Valve Stenosis — all drugs for Aortic Valve Stenosis →
Sponsor
Erasmus Medical Center
Who can join
18 and older, any sex, with Aortic Valve Stenosis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03196596
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03196596 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Erasmus Medical Center
- Last refreshed: 6 February 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03196596.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing