Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06397833
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-03
First Post:
2024-04-29
Brief Title:
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
Sponsor:
Royal Brompton Harefield NHS Foundation Trust
Organization:
Royal Brompton Harefield NHS Foundation Trust
Study Overview
Official Title:
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:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
There is a need for the development of a tool that can help to identify those HF patients at risk of deterioration The ideal tool would be quick easy to use non-invasive inexpensive and can be performed by any healthcare practitioner or patient themselves ie point of care testing
The Acorai Heart Monitor device is an extended smartphone case equipped with a combination of microphonic sensors inertial measurement units electrocardiographic sensors and photoplethysmography sensor in a configuration that is designed to enhance low frequency sound and seismic signals pertaining to intracardiac pressure Each sensor technology has been validated to minimize the risk to the patient Sensor data is collected to provide clinicians with the patients intracardiac pressures This is performed by placing the monitoring device on the chest with a small smart-wrist watch for a period of five minutes in the supine position A feasibility study showed Acorai device cardiac output measurements correlate highly with the gold standard right heart catheterisation RHC cardiac output measurement
Intracardiac pressure monitoring is important in HF patients Studies also show that raised right atrial pressure and pulmonary capillary wedge pressure are predictors of worse outcomes with increased risk of death cardiovascular hospitalisation or transplantation Clinicians can only gather intracardiac pressure measurements by undertaking a RHC procedure with fluoroscopy guidance However this is an invasive procedure with radiation exposure that carries risks including bleeding stroke infection and pneumothorax
This is a prospective observational single-site non-randomised non-significant risk single arm clinical investigation designed to collect non-invasive cardiac output measurements from the Acorai Heart Monitor device The objective of the study is to assess the feasibility of the Acorai ICPM system to predict survival and hospitalisation at 1 year in hospitalised heart failure patients deemed medically fit for discharge
The Acorai Heart Monitor device is an extended smartphone case equipped with a combination of microphonic sensors inertial measurement units electrocardiographic sensors and photoplethysmography sensor in a configuration that is designed to enhance low frequency sound and seismic signals pertaining to intracardiac pressure Each sensor technology has been validated to minimize the risk to the patient Sensor data is collected to provide clinicians with the patients intracardiac pressures This is performed by placing the monitoring device on the chest with a small smart-wrist watch for a period of five minutes in the supine position A feasibility study showed Acorai device cardiac output measurements correlate highly with the gold standard right heart catheterisation RHC cardiac output measurement
Intracardiac pressure monitoring is important in HF patients Studies also show that raised right atrial pressure and pulmonary capillary wedge pressure are predictors of worse outcomes with increased risk of death cardiovascular hospitalisation or transplantation Clinicians can only gather intracardiac pressure measurements by undertaking a RHC procedure with fluoroscopy guidance However this is an invasive procedure with radiation exposure that carries risks including bleeding stroke infection and pneumothorax
This is a prospective observational single-site non-randomised non-significant risk single arm clinical investigation designed to collect non-invasive cardiac output measurements from the Acorai Heart Monitor device The objective of the study is to assess the feasibility of the Acorai ICPM system to predict survival and hospitalisation at 1 year in hospitalised heart failure patients deemed medically fit for discharge
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None