An Exploratory Clinical Study Non-invasive Monitoring of Cardiac Outputs

An Exploratory Clinical Study for the Development of a Novel Ultrasound Transducer Technology Intended for Non-invasive Monitoring of Cardiac Outputs

Pulsify Medical aims at developing a sensor designed for the non-invasive, continuous and real-time monitoring of cardiac hemodynamics in patients at risk based on new transducer technology and artificial intelligence. It relies on real-time 3D greyscale ultrasound reconstruction of the LV myocardium. This medical device is still under development and the main objective of this clinical investigation is to gather data on the accuracy of the current version of the sensor developed by Pulsify Medical to further guide the development of the device. The data generated will not be used for conformity assessment and this single-center prospective study on 8 patients is therefore deemed appropriate for this purpose.

During the pretreatment visit, eligibility of the subjects for the investigation will be assessed. Once subjects are considered eligible and they have consented to participate in the investigation, the visit to perform the monitoring will be scheduled. An operator will then perform on each patient two scans with the Pulsify sensor. For accurate 3D reconstruction, the ECG and breathing cycle during the acquisition will also be recorded. Immediately after acquisition with the Pulsify sensor, an echocardiographist will record a complete 2D and 3D ultrasound data set using regular ultrasound equipment used for medical examinations in the hospital. The data generated will then be used to compare the accuracy of the Pulsify sensor for cardiac output measurements with state-of-the-art ultrasound. The data will also enable to acquire a dataset of ultrasound images taken with the Pulsify sensor technology in a manner that is very close to the image capture mechanism of Pulsify's final product.

Inclusion Criteria:

Healthy volunteers can participate in this study if they:

• are aged over 18 years old
• have no known cardiovascular diseases
• are willing and able to comply with all investigation related procedures

Exclusion Criteria:

• Volunteers with arrhythmias, PM or ICD
• Volunteers with life supporting electronic devices (e.g. pacemakers)
• Volunteers with bad echocardiographic windows
• Volunteers post recent thorax surgery and open chest wounds
• Volunteers with abnormal thorax configuration (COPD, scoliosis, pectus excavatum, etc.) on criteria for the selection of topics
• Women in gestation
• Women that are breastfeeding