About this trial
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)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subjects medically fit for discharge following an admission to Hospital with decompensated heart failure requiring intravenous diuretic therapy
Subject is willing and physically able to comply with the specified evaluations as per clinical investigation plan, as assessed by the investigator.
Subject is able to provide written consent to participate in the study
Disqualifiers
Pregnancy
Discretionary exclusion when, in the opinion of the investigator, the inclusion of a potential subject is not in their best interest or not in the interest of compliant performance of the clinical trial
Trial population
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.
Trial design
Case-only
Prospective
Treatments tested in this trial
Acorai ICPM system
DevicePatient will have the handheld Acorai ICPM system placed on their chest, for a period of 5 minutes for sensor recording time
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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
To evaluate which of the measurements provided by the Acorai ICPM system (PASP, mPAP, PADP, mPCWP, mRAP, CO, SV and PVR) best predict prognosis.
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