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Completed

NCT Number: NCT05104307

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)

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Key information

Conditions

Heart Diseases Cardiovascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UPMC Montefiore Hospital

Pittsburgh, Pennsylvania, 15212, United States

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Cardiac Performance System electronic data for Ejection Fraction

    Time frame: 60 minutes during Echocardiography procedure

    Cardiac function measurement including left ventricle ejection fraction to report in percentage

  2. Cardiac Performance System electronic data for Cardiac Output

    Time frame: 60 minutes during Echocardiography procedure

    Cardiac function metric measurement including Cardiac Output to report in L/m

  3. Cardiac Performance System electronic data for Pulmonary Artery Pressure

    Time frame: 60 minutes during Echocardiography procedure

    Cardiac function metric measurement including Pulmonary Artery Pressure to report in mmHg.

  4. Cardiac Performance System electronic data for Pulmonary Artery Wedge Pressure

    Time frame: 60 minutes during Echocardiography procedure

    Cardiac function metric measurement including Pulmonary Artery Wedge Pressure to report in mmHg

  5. Echocardiography electronic data for Ejection Fraction

    Time frame: 60 minutes during Echocardiography procedure

    Cardiac function measurement including left ventricle ejection fraction to report in percentage

  6. Echocardiography electronic data for Cardiac Output

    Time frame: 60 minutes during Echocardiography procedure

    Cardiac function metric measurement including Cardiac Output to report in L/m

  7. Echocardiography electronic data for Pulmonary Artery Pressure

    Time frame: 60 minutes during Echocardiography procedure

    Cardiac function metric measurement including Pulmonary Artery Pressure to report in mmHg.

  8. Echocardiography electronic data for Pulmonary Artery Wedge Pressure

    Time frame: 60 minutes during Echocardiography procedure

    Cardiac function metric measurement including Pulmonary Artery Wedge Pressure to report in mmHg

Sponsors and collaborators

Lead sponsor

Stephen Esper

Other

Collaborators

  • Sensydia Corporation

Registry information

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Nov 2, 2021
Registry last updated
May 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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