An observational study in Heart Failure and Decompensated Heart Failure, sponsored by Royal Brompton & Harefield NHS Foundation Trust. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-08.
Sponsored by Royal Brompton & Harefield NHS Foundation Trust · Observational
Acorai is developing the Acorai Heart Monitor, a handheld electronic device for monitoring pressures inside the heart in a non-invasive manner, by placing the device on the chest of a patient. Currently these intracardiac pressures are measured in an invasive way, during a right heart catheterisation procedure. This procedure carries risks to the patient. There is a clinical need for a non -invasive, easy to use, tool to monitor patients that suffer from heart failure. The study aim is to use the Acorai device to collect the intracardiac pressure measurements from patients admitted to hospital with heart failure and who are awaiting discharge home. Using the data, we will assess the feasibility of the Acorai derived cardiac output measurements, and assess what data best predicts survival, death, or major adverse cardiac events (MACE)
There is a need for the development of a tool that can help to identify those HF patients at risk of deterioration. The ideal tool would be quick, easy to use, non-invasive, inexpensive and can be performed by any healthcare practitioner or patient themselves (i.e. point of care testing).
The Acorai Heart Monitor device is an extended smartphone case equipped with a combination of microphonic sensors, inertial measurement units, electrocardiographic sensors and photoplethysmography sensor, in a configuration that is designed to enhance low frequency sound and seismic signals pertaining to intracardiac pressure. Each sensor technology has been validated to minimize the risk to the patient. Sensor data is collected to provide clinicians with the patients intracardiac pressures. This is performed by placing the monitoring device on the chest, with a small smart-wrist watch, for a period of five minutes in the supine position. A feasibility study showed Acorai device cardiac output measurements correlate highly with the gold standard right heart catheterisation (RHC) cardiac output measurement.
Intracardiac pressure monitoring is important in HF patients. Studies also show that raised right atrial pressure and pulmonary capillary wedge pressure are predictors of worse outcomes with increased risk of death, cardiovascular hospitalisation or transplantation. Clinicians can only gather intracardiac pressure measurements by undertaking a RHC procedure with fluoroscopy guidance. However, this is an invasive procedure, with radiation exposure, that carries risks including bleeding, stroke, infection and pneumothorax.
This is a prospective, observational, single-site, non-randomised, non-significant risk, single arm, clinical investigation designed to collect non-invasive cardiac output measurements from the Acorai Heart Monitor device The objective of the study is to assess the feasibility of the Acorai ICPM system to predict survival and hospitalisation at 1 year in hospitalised heart failure patients deemed medically fit for discharge.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's planned enrollment of 150 is below the median of 200 across 1,679 observational studies indexed under Heart Failure.
Browse Heart Failure studies →Royal Brompton & Harefield NHS Foundation Trust is the lead sponsor of 137 studies on the registry; 18 are open to participants now.
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The study population will include all subjects, over the age of 18 years, who have been admitted to hospital with decompensated heart failure, requiring intravenous diuretic therapy.
Inclusion Criteria: Subjects must meet all the following criteria to be eligible for participation in the clinical investigation
Exclusion Criteria:
Patient has been admitted to hospital with decompensated heart failure, received at least one dose of an intravenous diuretic, and are awaiting discharge home following their treatment.
Device: Acorai ICPM system
Patient will have the handheld Acorai ICPM system placed on their chest, for a period of 5 minutes for sensor recording time
To assess the feasibility of the Acorai ICPM system to predict survival and hospitalisation at 1 year in hospitalised heart failure patients deemed medically fit for discharge.
Time frame: 1 year
To assess the feasibility of the Acorai ICPM system to predict Major adverse cardiac events (MACE) 1 year in hospitalised heart failure patients deemed medically fit for discharge.
MACE includes: acute coronary syndrome (ACS), stroke, cardiovascular related death, heart failure related admission, arrythmia, heart transplantation, mechanical circulatory support
Time frame: 1 year
To evaluate which of the measurements provided by the Acorai ICPM system (PASP, mPAP, PADP, mPCWP, mRAP, CO, SV and PVR) best predict prognosis.
Time frame: 1 year
Plan to share: No
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Royal Brompton & Harefield NHS Foundation Trust