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EchoNavigator 3D Models


- candidate number24092
- NTR NumberNTR5718
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR11-mrt-2016
- Secondary IDsDHF250438 Philips Medical Systems b.v.
- Public TitleEchoNavigator 3D Models
- Scientific TitleEchoNavigator R3 Investigational Device; The Clinical Value of 3D TEE Models for Structural Heart Disease Procedures
- ACRONYM
- hypothesisTo determine the clinical value and impact of 3D TEE models for image guidance during SHD interventions in both a qualitative and quantitative approach:
Qualitative: do the models help in understanding the relation between the cardiac structures from echo and the projected X-ray fluoroscopy image to support imaging and device guidance
Quantitative: by a comparative measurement of structures provided by the 3D model and manual placed annotations
- Healt Condition(s) or Problem(s) studiedHeart diseases
- Inclusion criteriaPatients that require one of the following SHD interventions for which routine fluoroscopy and TEE guidance is used: MitraClip placement on the mitral valve (TMVR), left atrial appendage closure (LAAC), trans catheter aortic valve implantation (TAVI)
Subject is 18 years of age or older, or of legal age to give informed consent per state or national law
- Exclusion criteria-Patients who are unsuitable to accept TEE imaging during a SHD intervention, further descibed in the Clinical Research Plan.
-Subject participates in a potentially confounding drug or device trial during the course of the study.
-Subject meets an exclusion criteria according to national law (e.g. Age, pregnant woman, breast feeding woman)
- mec approval receivedno
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-mei-2016
- planned closingdate1-nov-2016
- Target number of participants30
- InterventionsNo interventions to the normal way of working in the protocol, study is observational.
- Primary outcomeThe primary endpoint is a qualitative and quantitative assessment by comparing the distances between annotations genered automatically by the model with manual annotated structures and/or validating the position of the annotations by contrast enhanced X-ray angio or the location of X-ray opaque structures (e.g. devices) on the X-ray image.
- Secondary outcomeSecondary endpoints are qualitative feedback on the user interfaceto improve the investigational device, eecorded anonymized raw Echo and X-ray data to tune algorithm parameters and qualitative to improve future versions of the EchoNavigator device.
- TimepointsThe patients will be participating in the trial for the duration of the procedure. No-follow-up is required per protocol.
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESProf. Dr. Roberto Corti
- CONTACT for SCIENTIFIC QUERIES Niels Nijhof
- Sponsor/Initiator Philips Medical Systems Nederland B.V.
- Funding
(Source(s) of Monetary or Material Support)
Philips Medical Systems Nederland B.V.
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD11-mrt-2016 - 2-mei-2016


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl