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

Launched by ROYAL BROMPTON & HAREFIELD NHS FOUNDATION TRUST · Apr 29, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring a new tool called the Acorai Heart Monitor, which is a handheld device that can measure pressures inside the heart without the need for invasive procedures. Traditionally, measuring these pressures requires a procedure that involves inserting a catheter into the heart, which can pose risks to patients. The aim of the study is to see if the information gathered from the Acorai device can help predict how well patients with heart failure will do after they leave the hospital, specifically whether they are likely to survive or experience serious heart-related issues.

To participate in this study, patients must be discharged from the hospital after receiving treatment for heart failure and be able to follow the study guidelines. They should also be able to give consent to participate. The trial is open to all adults aged 65 and older who meet these criteria. If someone joins the study, they can expect to use the Acorai Heart Monitor to collect important heart data during their hospital stay, helping researchers understand how this new device might improve care for heart failure patients in the future.

Gender

ALL

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