No registrations found.
ID
Source
Brief title
Health condition
Structural Heart Diseases (SHD)
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
The study investigates concept and feasibility of view automation for SHD interventions. The study will explore the contribution of semi-automatic views based procedural context, anatomy and device information on the ease of use and efficiency of the procedure.
Study objective
Semi-automatic views contribute to the ease of use and efficiency of the procedure.
Study design
The patients will be participating in the trial for the duration of the procedure. No-follow-up is required per protocol.
Intervention
No interventions to the normal way of working in the protocol, study is observational. Patients will receive standard of clinical care.
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
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
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL9468 |
| Other | Philips Medical Systems B.V. : D000785186rA |