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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
United Kingdom
Harefield Hospital
RECRUITING
Uxbridge
Contact Information
Primary
Owais Dar, MB ChB MD Res
o.dar@rbht.nhs.uk
01895828933
Backup
Ramey Assaf, MBBS BMedSci
r.assaf@rbht.nhs.uk
01895828933
Time Frame
Start Date: 2024-04-29
Estimated Completion Date: 2027-02-01
Participants
Target number of participants: 150
Treatments
Decompensated Heart Failure Group
Patient has been admitted to hospital with decompensated heart failure, received at least one dose of an intravenous diuretic, and are awaiting discharge home following their treatment.
Related Therapeutic Areas
Sponsors
Leads: Royal Brompton & Harefield NHS Foundation Trust

This content was sourced from clinicaltrials.gov