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

NCT05104307 | Completed FDA Device

• 1 other identifier: STUDY21050167
• Study Type: observational
• Target: 79
• Locations: 1 country
• Sites: 1

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)

Conditions

Heart Diseases

Keywords

cardiovascular

Outcome Measures

Primary Outcomes (8)

• 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

Study Arms (1)

Cardiac Performance System (NSR)

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

Device: Cardiac Performance System (CPS) Device

Interventions

Cardiac Performance System (CPS) Device 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.

Cardiac Performance System (NSR)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled for a standard echocardiogram

You may qualify if:

• Patients over 18 scheduled for a standard echocardiogram

You may not qualify if:

• 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

Sponsors & Collaborators

• Stephen Esper: lead
• Sensydia Corporation: collaborator

Study Sites (1)

UPMC Montefiore Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

• Stephen L Esper, MD, MBA

  University of Pittsburgh Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 14, 2021
• First Posted: November 2, 2021
• Study Start: November 9, 2021
• Primary Completion: January 2, 2024
• Study Completion: January 2, 2024
• Last Updated: May 6, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)