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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRoyal Brompton & Harefield NHS Foundation Trust

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 volunteers

Qualifiers

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

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • Acorai ICPM system

    Device

    Patient will have the handheld Acorai ICPM system placed on their chest, for a period of 5 minutes for sensor recording time

Treatment groups

150 Participants
are divided into 1 treatment group
Group A: Decompensated Heart Failure Group1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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

Other outcomes

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