RecruitingNCT06397833

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

Enrollment

150 participants

Start Date

Apr 29, 2024

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This feasibility study tests whether wearable monitoring devices (like fitness trackers or smart patches) can effectively track recovery in patients after cardiac (heart) surgery, providing continuous data on heart rate, activity levels, and other health indicators. **You may be eligible if...** - You are scheduled for or have recently had cardiac surgery (such as bypass surgery or valve replacement) - You are willing to wear monitoring devices during your recovery - You are at least 18 years old **You may NOT be eligible if...** - You have a pacemaker or implanted device that would be affected by the wearable technology - You have skin conditions or allergies that prevent wearing adhesive monitoring devices - You have cognitive difficulties that prevent proper use of or consent for the devices Talk to your doctor to see if this trial is right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interventions

DEVICEAcorai 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

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NCT06397833


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