An Exploratory Clinical Study Non-invasive Monitoring of Cardiac Outputs

NACompletedINTERVENTIONAL
Enrollment

8

Participants

Timeline

Start Date

October 19, 2022

Primary Completion Date

January 23, 2023

Study Completion Date

January 23, 2023

Conditions
Cardiac Output MeasurementsHealthy 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

Trial Locations (1)

3000

UZ Leuven, Leuven

All Listed Sponsors
collaborator

KU Leuven

OTHER

collaborator

Universitaire Ziekenhuizen KU Leuven

OTHER

lead

Pulsify Medical

INDUSTRY