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
| NCT ID | NCT06397833 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Royal Brompton & Harefield NHS Foundation Trust |
| Condition | Heart Failure |
| Study Type | OBSERVATIONAL |
| Enrollment | 150 participants |
| Start Date | 2024-04-29 |
| Primary Completion | 2026-02-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 150 participants in total. It began in 2024-04-29 with a primary completion date of 2026-02-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06397833 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Heart Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06397833 currently recruiting?
Yes, NCT06397833 is actively recruiting participants. Contact the research team at o.dar@rbht.nhs.uk for enrollment information.
Where is the NCT06397833 trial being conducted?
This trial is being conducted at Uxbridge, United Kingdom.
Who is sponsoring the NCT06397833 clinical trial?
NCT06397833 is sponsored by Royal Brompton & Harefield NHS Foundation Trust. The trial plans to enroll 150 participants.
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