heart valve disease Structural Heart Disease (SHD)
Conditions
Interventions
EchoNavigator SmartVue Investigational Device
Sponsors
Philips
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Subject is a patient that requires SHD intervention for which routine fluoroscopy and TEE guidance is used, such as: transcatheter mitral and tricuspid therapies (TTMT), left atrial appendage closure (LAAC), trans catheter aortic valve replacement (TAVR). Subject is able to give informed consent and is 18 years of age or older, or of legal age to give informed consent per state or national law.
Exclusion criteria
Exclusion criteria: Subjects who are unsuitable to accept TEE imaging during a structural heart disease intervention - Subject is an adult who lacks the capacity provide consent - Subject is in an emergency condition - Subject participates in a potentially confounding drug or device trial during the course of the study - All vulnerable subjects, or any other subject who meets an exclusion criteria, according to applicable national laws, if any. * Subject is pregnant or breast feeding woman * Subject is Philips employee their family members residing with this Philips employee.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of the study is a qualitative assessment of the usefulness, accuracy and contribution to efficiency of automated views as proposed by the EchoNavigator SmartVue Investigational Device. The qualitative assessment will be based on a relative scale (e.g. ranging from *very useful* to *not useful*). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are: - Recorded anonymized raw Echo and X-ray data that can be used to develop (AI) algorithms used for view automation, and automatic (flow) quantification - Qualitative feedback on the user interface and the workflow that may be used to improve the investigational device - Feedback on existing functionality and suggestions for new functionality to improve future versions of the EchoNavigator device | — |
Countries
Netherlands
Contacts
Public ContactN Nijhof
Philips
Outcome results
None listed