Echocardiogram and Cardiac Performance System (CPS) Ejection Fraction Validation Study

Heart Diseases Clinical Trial

Official title:

Echocardiogram and Cardiac Performance System (CPS) Ejection Fraction Validation Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05104307
• Other study ID #: STUDY21050167
• Status: Completed
• Start date: November 9, 2021
• Est. completion date: January 2, 2024

Study information

• Verified date: May 2024
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Non-significant risk device study to conduct evaluation of the performance of new device for monitoring of cardiac function (based on previous iterations 510(k) 173156)

Description:

This validation study will help to establish feasibility of using the CPS monitor to screen patients for ejection fraction (EF), CO, PASP and wedge pressure compared to a standard echocardiogram. No clinical decisions will be made as a result of the CPS device EF value and this measurement will be taken for comparison purposes only.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: January 2, 2024
• Est. primary completion date: January 2, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients over 18 scheduled for a standard echocardiogram

Exclusion Criteria:

• Patients with heart transplant history
• Patients with a Implanted Left Ventricular Assist Device (LVAD)
• Patients who have surgical scars, wounds, or bandages at the site of sensor placement
• Inadequate TTE imaging windows in left lateral position
• Otherwise deemed by the investigator as medically unfit to participate
• Chest deformities including, for example, pectus excavatum

Related Conditions & MeSH terms

• Heart Diseases

Intervention

Device:
• Cardiac Performance System (CPS) Device
CPS is a passive measurement system that acquires signals from multiple sensor sources that monitor cardiac heart sounds. The passive sensor systems measure sound only and do not produce energy. The CPS system also includes a Patient Monitor device that acquires data from the sensors as well as from three standard ECG electrodes. The CPS system does not acquire or store any protected health information or any subject characteristics. The CPS system has received FDA clearance K173156. Note that the CPS system was previously named Integrated CardioRespiratory (ICR) system. The CPS is FDA cleared for the ejection fraction (EF) assessment which will be its intended use for this study.

Locations

Country	Name	City	State
United States	UPMC Montefiore Hospital	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Stephen Esper	Sensydia Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac Performance System electronic data for Ejection Fraction	Cardiac function measurement including left ventricle ejection fraction to report in percentage	60 minutes during Echocardiography procedure
Primary	Cardiac Performance System electronic data for Cardiac Output	Cardiac function metric measurement including Cardiac Output to report in L/m	60 minutes during Echocardiography procedure
Primary	Cardiac Performance System electronic data for Pulmonary Artery Pressure	Cardiac function metric measurement including Pulmonary Artery Pressure to report in mmHg.	60 minutes during Echocardiography procedure
Primary	Cardiac Performance System electronic data for Pulmonary Artery Wedge Pressure	Cardiac function metric measurement including Pulmonary Artery Wedge Pressure to report in mmHg	60 minutes during Echocardiography procedure
Primary	Echocardiography electronic data for Ejection Fraction	Cardiac function measurement including left ventricle ejection fraction to report in percentage	60 minutes during Echocardiography procedure
Primary	Echocardiography electronic data for Cardiac Output	Cardiac function metric measurement including Cardiac Output to report in L/m	60 minutes during Echocardiography procedure
Primary	Echocardiography electronic data for Pulmonary Artery Pressure	Cardiac function metric measurement including Pulmonary Artery Pressure to report in mmHg.	60 minutes during Echocardiography procedure
Primary	Echocardiography electronic data for Pulmonary Artery Wedge Pressure	Cardiac function metric measurement including Pulmonary Artery Wedge Pressure to report in mmHg	60 minutes during Echocardiography procedure