The Contribution of EchoNavigator Workflow Improvements on Efficiency for SHD Procedures

The EchoNavigator SmartVue Investigational Device is developed by Philips
Medical Systems. The proposed EchoNavigator SmartVue Investigational Device is
a based on the released EchoNavigator R3 software medical device. The intended
use, clinical setting and intended operator profile of the investigational
device are identical to the EchoNavigator R3 software medical device. Similar
to the product, the device is an *assistive device*, procedures can be
performed safely and effectively without the device: the device does not alter
the clinical workflow and does not replace existing clinical (imaging) data.

EchoNavigator is a software medical device which is used during minimal
invasive Structural Heart Disease (SHD) interventions where live X-ray and
Ultrasound imaging is required. EchoNavigator allows the clinical operator to
merge X-ray and Ultrasound images, and place markers on the images to provide
the clinical operator a better understanding of the anatomy and assist with
device guidance.

Features of EchoNavigator software medical device are:
• Giving procedural-relevant context to the live X-ray and ultrasound data by:
o Automatically synchronizing the image orientation of both modalities (by use
of the *Orientation Indicator* similar to 3DRA product), as opposed to relying
solely on the echo-operator to create this context manually.
o Automatically aligning the Echo views (including MPR) to a clinically
relevant orientation after the user selects the required anatomical preset.
o Automatically aligning the Echo views (including MPR) to a clinically
relevant orientation based on procedural context, anatomy and device
information.
• Allowing to the visualization of relevant anatomical structures in the live
Echo data in multiple simultaneous user defined views
• Automatically presenting the Echo data in the same orientation as the live
X-ray images from the X-ray system (so called *Follow C-arm*), as opposed to
relying on the echo-operator to provide this orientation
• Allowing the X-ray user to interrogate the relevant anatomical structures in
the Echo data from table side, as opposed to requesting the echo-operator to
perform the interrogation
• Allowing the user to identify anatomical structures in one modality and
annotate them manually with annotations. These annotations are automatically
transposed to the other modality. The annotations are visualized in all
selected views and are solely intended to be used as context information to
help the user with the navigation of the catheter and device in the patient*s
anatomy.
• Allowing the user to identify anatomical structures in the echo modality and
annotate them with annotations and tissue contours as proposed by the device.
These annotations are automatically transposed to the X-ray modality. The
annotations are visualized in all selected views and are solely intended to be
used as context information to help the user with the navigation of the
catheter and device in the patient*s anatomy.
• Project the Ultrasound image or volume as overlay or only outline on top of
the X-ray view
• Allowing the Echo operator to view and annotate the X-ray image from the Echo
console

Compared to the EchoNavigator R3 product, the novel feature in the
EchoNavigator SmartVue Investigational Device is view automation based on
procedural context (e.g. procedure type, step of the procedure), anatomical
information (e.g. from automatic segmentation echo data, imported CT or from
AI) and device information. View automation may contribute to easier control of
the imaging and a more efficient clinical workflow, as the echo operator does
not need to adjust the views manually.

The primary objective of this clinical Research is:
• The objective of the study is to investigate 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

The objectives are descriptive in nature and are intended to provide additional
information. There will be no pass or fail criteria.

The secondary objective is/are:
• Collect image data for further (AI) algorithm development and automatic
(flow) quantification
• Collect usability feedback to improve the user interface
• Collect clinical user feedback for potential future improvements of the device
• Report all adverse events
• Report all adverse device effects
• Report all device deficiencies that could have led to a serious adverse event

The objectives are descriptive in nature and are intended to provide additional
information. There will be no pass or fail criteria.

This is a prospective, non-randomized, unblinded, observational, single-center
study.

Agreement(s) will be set-up between sponsor and investigational site(s),
including roles and responsibilities and financial or in-kind compensations and
ensure that any reportable events are notified by the investigator(s) to the
sponsor in a timely manner.

During this study 1 (one) investigational device will be used: EchoNavigator
SmartVue Investigational Device R1.1

There are no comparators. There are no additional devices or medications
required for the study.

The risk assessment process that Philips follows is in accordance with ISO
14971.This will ensure that the level of risk is acceptable prior to start of
the study.

The anticipated clinical benefits of the EchoNavigator functionality in general
are:
• Improved understanding of ultrasound
• Improved understanding of the relationship between X-ray and ultrasound
• Improved communication between Echocardiographer/sonographer and
Interventional cardiologist/operator
• Support for device guidance and navigation
• Increased control from table side

The additional anticipated clinical benefits of the SmartVue Investigational
Device functionality are:
• Easier control of the imaging and a more efficient clinical workflow

There is a possibility that the patient may not benefit from participating in
the study, however patients participating in the study receive the normal
standard of care that they would also receive when they would not participate
in the study.

There are no possible interactions with concomitant medical treatments.

The outcome of the Safety Risk Assessment for this device is that the residual
risks for the investigational device are outweighed by the medical benefits and
safety and performance of the device. Therefore, on the basis of both clinical
evaluation and risk profile, study of the investigational device under the
conditions described in clinical study plan is justified.