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RECRUITING
NCT06397833

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

Sponsor: Royal Brompton & Harefield NHS Foundation Trust

View on ClinicalTrials.gov

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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

150

Start Date

2024-04-29

Completion Date

2027-02-01

Last Updated

2025-04-08

Healthy Volunteers

No

Interventions

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

Locations (1)

Harefield Hospital

Uxbridge, Middlesex, United Kingdom