Actively Recruiting

Age: 18Years +
All Genders
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

Led by Royal Brompton & Harefield NHS Foundation Trust · Updated on 2025-04-08

150

Participants Needed

1

Research Sites

144 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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)

CONDITIONS

Official 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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • Pregnancy
  • Investigator discretion to exclude if participation is not in the subject's best interest or would affect trial compliance

AI-Screening

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Trial Site Locations

Total: 1 location

1

Harefield Hospital

Uxbridge, Middlesex, United Kingdom, UB9 6JH

Actively Recruiting

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Research Team

O

Owais Dar, MB ChB MD Res

CONTACT

R

Ramey Assaf, MBBS BMedSci

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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