Structural Heart Diseases (SHD)
Conditions
Sponsors
Philips Medical Systems B.V.
Eligibility
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 Investigational Device. | — |
Secondary
| Measure | Time frame |
|---|---|
| Qualitative feedback on the user interface and the workflow that may be used to improve the investigational device, clinical user feedback for potential future improvements of the device. | — |
Contacts
Public ContactNiels Nijhof
Philips Medical Systems B.V.
Outcome results
None listed