An Exploratory Clinical Study Non-invasive Monitoring of Cardiac Outputs

Summary

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.

Conditions

• Cardiac Output Measurements
• Healthy Subjects

Interventions

DEVICE

Pulsify sensor

A positioning system will move the 1X1 cm Pulsify sensor step-by-step over a marked area of 10x10 cm on the subjects' chest to record a complete 3D data set of the heart. For accurate 3D reconstruction, the ECG and breathing cycle are also recorded during the acquisition using commercially available devices (Bitalino HeartBIT + Respiration Sensor). From the 3D dataset of the heart, the end-systolic and end-diastolic volumes will be extracted automatically to calculate the cardiac output.

DEVICE

State-of-the-art ultrasound equipment

A complete 2D and 3D ultrasound data set using a GE Vivid E95 ultrasound machine, version 203 (General Electric Healthcare, Chicago, IL, United States) will be recorded. All data will be processed offline with a specialized software packet (EchoPAC, version 203, General Electric Healthcare, Chicago, IL, United States

Sponsors & Collaborators

• KU Leuven

  collaborator OTHER

• Universitaire Ziekenhuizen KU Leuven

  collaborator OTHER

• Pulsify Medical

  lead INDUSTRY

Principal Investigators

• Alexander Van De Bruaene · UZ Leuven

• Lieven Herbots · Pulsify Medical

Study Design

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-10-19

Primary Completion

2023-01-23

Completion

2023-01-23

Countries

• Belgium

Study Locations