Structural Heart Disease procedures
Conditions
Interventions
Structural Heart Disease procedures:
-MitraClip placement on the mitral valve (TMVR), -left atrial appendage closure (LAAC),
-trans catheter aortic valve implantation (TAVI)
Sponsors
Philips Medical Systems Nederland B.V
Eligibility
Inclusion criteria
Inclusion criteria: -Patients 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
Exclusion criteria: -Patients who are unsuitable to accept TEE imaging during a SHD intervention (indications when not to include specified in protocol) -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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The 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
| Measure | Time frame |
|---|---|
| Secondary endpoints are qualitative feedback on the user interfaceto improve the investigational device, recorded anonymized raw Echo and X-ray data to tune algorithm parameters and qualitative to improve future versions of the EchoNavigator device. | — |
Contacts
Public ContactNiels Nijhof
Philips Medical Systems Nederland B.V
Outcome results
None listed