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

Summary

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

Inclusion Criteria: Subjects must meet all the following criteria to be eligible for participation in the clinical investigation

1. Subjects medically fit for discharge following an admission to Hospital with decompensated heart failure requiring intravenous diuretic therapy
2. Subject is willing and physically able to comply with the specified evaluations as per clinical investigation plan, as assessed by the investigator.
3. Subject is able to provide written consent to participate in the study

Exclusion Criteria:

1. Pregnancy
2. 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

Conditions3

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