Using a new device to monitor heart pressure in patients recovering from heart failure
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
This study is testing a new device that measures heart pressure in patients recovering from heart failure to see if it can help doctors predict who might get worse and improve their care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Royal Brompton & Harefield NHS Foundation Trust Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Uxbridge, Middlesex) |
| Trial ID | NCT06397833 on ClinicalTrials.gov |
What this trial studies
This study evaluates the Acorai Heart Monitor, a non-invasive device designed to measure intracardiac pressures in patients discharged from the hospital after treatment for acute decompensated heart failure. By placing the device on the patient's chest, it collects data on cardiac output and intracardiac pressures, which are crucial for predicting patient outcomes. The goal is to determine the feasibility of using this device to identify patients at risk of deterioration and to assess which data points best predict survival and major adverse cardiac events. This approach aims to provide a quick, easy-to-use monitoring tool that can be utilized by healthcare practitioners or patients themselves.
Who should consider this trial
Good fit: Ideal candidates for this study are patients who are medically fit for discharge after treatment for decompensated heart failure and require intravenous diuretic therapy.
Not a fit: Patients who are pregnant or those deemed unsuitable for the study by the investigator may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved monitoring and management of heart failure patients, potentially reducing hospital readmissions and improving survival rates.
How similar studies have performed: While similar studies have explored non-invasive monitoring techniques, the specific use of the Acorai device in this context is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Subjects must meet all the following criteria to be eligible for participation in the clinical investigation 1. Subjects medically fit for discharge following an admission to Hospital with decompensated heart failure requiring intravenous diuretic therapy 2. Subject is willing and physically able to comply with the specified evaluations as per clinical investigation plan, as assessed by the investigator. 3. Subject is able to provide written consent to participate in the study Exclusion Criteria: 1. Pregnancy 2. 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
Where this trial is running
Uxbridge, Middlesex
- Harefield Hospital — Uxbridge, Middlesex, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Owais Dar, MB ChB MD Res
- Email: o.dar@rbht.nhs.uk
- Phone: 01895828933
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.