No registrations found.
ID
Source
Health condition
Structural Heart Disease procedures: LAAC, TMVR and TAVI
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
Secondary 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.
Study objective
To 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
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.
Roberto Corti
Witellikerstrasse 40
Zurich 8032
Switzerland
Roberto Corti
Witellikerstrasse 40
Zurich 8032
Switzerland
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
-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)
Design
Recruitment
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 | NL5612 |
| NTR-old | NTR5718 |
| Other | Philips Medical Systems b.v. : DHF250438 |