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Tests a heart pressure monitor in people leaving hospital with heart failure

Checks whether a chest-placed device can predict outcomes in adults with heart failure.

Plain-language title generated from the registry record
Registry title: A Prospective, Observational, Single Centre Study to Assess the Feasibility of the Data Harvested by the Acorai Intracardiac Pressure Monitoring (ICPM) System in Predicting Prognosis in Patients Discharged From Hospital After Treatment for Acute Decompensated Heart Failure

Key facts

Where
Uxbridge, United KingdomSee the site

Where in United Kingdom

  • Harefield HospitalUxbridge, United KingdomTaking people

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Trial details

Who runs it
Royal Brompton & Harefield NHS Foundation Trust
Trial code
NCT06397833
Record updated
8 April 2025
Original description
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)Read full original descriptionShow less

A Prospective, Observational, Single Centre Study to Assess the Feasibility of the Data Harvested by the Acorai Intracardiac Pressure Monitoring (ICPM) System in Predicting Prognosis in Patients Discharged From Hospital After Treatment for Acute Decompensated Heart Failure

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)

Inclusion: 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.

Exclusion: 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.

ClinicalTrials.gov NCT06397833