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Completed

NCT Number: NCT04131725

Cardiac Function Non-Invasive Monitoring System Evaluation Trial

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

Cardiac Disease Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15261, United States

About this 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)

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Adults of age 18 or older

Exclusion criteria

  • Subjects with wounds or surgical incisions at the site of sensor placement

Treatment and study plan

Cardiac Performance System (NSR)

Device

Device: Cardiac Performance System Participants will be asked to wear the Cardiac Performance System, a non-invasive sensor device on their upper abdomen. The Cardiac Performance System monitoring device will continuously monitor cardiac function. The device will be worn at the time when Pulmonary Artery Catheter procedures are conducted.

Primary outcomes

  1. Cardiac Performance System electronic data for Cardiac Output

    Time frame: 60 minutes during Pulmonary Artery Catheter procedure

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

  2. Cardiac Performance System electronic data for Pulmonary Artery Pressure

    Time frame: 60 minutes during Pulmonary Artery Catheter procedure

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

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

    Time frame: 60 minutes during Pulmonary Artery Catheter procedure

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

  4. Pulmonary Artery Catheter electronic data for Cardiac Output

    Time frame: 60 minutes during Pulmonary Artery Catheter procedure

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

  5. Pulmonary Artery Catheter electronic data for Pulmonary Artery Pressure

    Time frame: 60 minutes during Pulmonary Artery Catheter procedure

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

  6. Pulmonary Artery Catheter electronic data for Pulmonary Artery Wedge Pressure

    Time frame: 60 minutes during Pulmonary Artery Catheter procedure

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

  7. Echocardiography electronic data for Ejection Fraction

    Time frame: 15 minutes at a time prior to or after Pulmonary Artery Catheter procedure

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

Sponsors and collaborators

Lead sponsor

Sensydia Corporation

Industry

Collaborators

  • University of Pittsburgh Medical Center

Registry information

Official study title

Cardiac Function Monitoring System Evaluation

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Oct 18, 2019
Registry last updated
Nov 22, 2023

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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