NCT06397833Recruiting
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
Source: ClinicalTrials.gov · Last updated 8 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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)
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 150 (estimated)
- First submitted
- 29 Apr 2024
- Start date
- 29 Apr 2024
- Primary completion date
- 1 Feb 2026
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation Trust
- Diseases
- Heart failure
- NCT number
- NCT06397833
What you commit to
- Study type: Observational
- Planned participants: 150
- From 29 Apr 2024 to the primary completion date, 1 Feb 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Harefield Hospital Coordinator of this site? Confirm its status | Uxbridge | United Kingdom | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.