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

Completed

• Conditions: Heart Diseases
• Interventions: Device: Cardiac Performance System (CPS) Device

• Registration Number: NCT05104307
• Lead Sponsor: Stephen Esper

Brief 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)

Detailed 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.

Study Timeline

• Study First Submitted: 2021-10-14
• Study First Submitted QC: 2021-10-28
• Study First Posted: 2021-11-02
• Study Start: 2021-11-09
• Primary Completion: 2024-01-02
• Study Completion: 2024-01-02
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-03
• Last Update Posted: 2024-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 79

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cardiac Performance System (NSR)	Cardiac Performance System (CPS) Device	Subjects will wear Cardiac Performance System (CPS) non-invasive device during their standard echocardiogram

Primary Outcome Measures

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

Trial Locations

Locations (1)

UPMC Montefiore Hospital; 🇺🇸 Pittsburgh, Pennsylvania, United States