Acorai MLG Study
Research type
Research Study
Full title
“A Multi-Site Observational Clinical Investigation to Collect Non-invasive Sensor Data During a Right Heart Catheterization and Train Machine Learning Models to Estimate Intracardiac Hemodynamic Parameters”
IRAS ID
328221
Contact name
Helmine Verhoeven
Contact email
Sponsor organisation
Acorai AB
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 6 months, 2 days
Research summary
Acorai is developing the Acorai Heart Monitor, a handheld electronic device for monitoring pressures inside the heart in a non-invasive way, simply by placing the device on the chest of a patient. Currently these intracardiac pressures are measured in an invasive way, during a catheterisation. There is a clinical need for a non -invasive, easy to use, tool to monitor patients that (may) suffer from heart failure. For the development of the monitor, Acorai is conducting a data collection study. Data from patients undergoing a right heart catheterisation is collected and used to built the software needed for the final device, the heart monitor. People undergoing a right heart cath will be invited to participate. Hospital from the UK, US and Europe will be involved in this study. A total of 1200 patients will be participating.
REC name
London - Surrey Research Ethics Committee
REC reference
23/PR/0556
Date of REC Opinion
26 Jul 2023
REC opinion
Further Information Favourable Opinion