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

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)

Study Overview

• Status: Completed
• Conditions: Heart Diseases
• Intervention / Treatment: Device: Cardiac Performance System (CPS) Device

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 Type: Observational
• Enrollment (Actual): 79

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15212
      • UPMC Montefiore Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled for a standard echocardiogram

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Cardiac Performance System (NSR); Subjects will wear Cardiac Performance System (CPS) non-invasive device during their standard echocardiogram

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
Echocardiography electronic data for Ejection Fraction	Cardiac function measurement including left ventricle ejection fraction to report in percentage	60 minutes during Echocardiography procedure
Echocardiography electronic data for Cardiac Output	Cardiac function metric measurement including Cardiac Output to report in L/m	60 minutes during Echocardiography procedure
Echocardiography electronic data for Pulmonary Artery Pressure	Cardiac function metric measurement including Pulmonary Artery Pressure to report in mmHg.	60 minutes during Echocardiography procedure
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

Collaborators and Investigators

• Sponsor: Stephen Esper
• Collaborators: Sensydia Corporation
• Investigators: Principal Investigator: Stephen L Esper, MD, MBA, University of Pittsburgh Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2021
• Primary Completion (Actual): January 2, 2024
• Study Completion (Actual): January 2, 2024

Study Registration Dates

• First Submitted: October 14, 2021
• First Submitted That Met QC Criteria: October 28, 2021
• First Posted (Actual): November 2, 2021

Study Record Updates

• Last Update Posted (Actual): May 6, 2024
• Last Update Submitted That Met QC Criteria: May 3, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: cardiovascular
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases
• Other Study ID Numbers: STUDY21050167

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No