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Echocardiogram and Cardiac Performance System (CPS) Ejection Fraction Validation Study | Clinical Trials | Clareo Health

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

NCT05104307•Stephen Esper

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (1)

UPMC Montefiore Hospital

Pittsburgh, Pennsylvania, United States

Key Dates

Start Date

November 9, 2021

Primary Completion Date

January 2, 2024

Completion Date

January 2, 2024

Last Updated

May 6, 2024

Enrollment

ACTUAL participants

Conditions

Heart Diseases

Interventions

Cardiac Performance System (CPS) Device

DEVICE

Lumason® Infusion vs. Bolus Administrations

NCT06400004

Heart Diseases

View study

RECRUITINGNA

Aerobic Exercise-induced Effect on Endothelial Function in Patients With Ischaemic Heart Disease

NCT06788275

Percutaneous Coronary Intervention (PCI)Acute Myocardial Infarction+4 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 6, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Lumason® Infusion vs. Bolus Administrations

Aerobic Exercise-induced Effect on Endothelial Function in Patients With Ischaemic Heart Disease

Abbott Structural Heart Device Registry

Single vs. Dual Antiplatelet Therapy in Elderly or HBR Patients Undergoing Percutaneous Intervention With DCB (PICCOLETO IV-EPIC 38)

Use of Bedside Imaging and Community Health Workers for Early Screening and Referral of Pre-symptomatic Stage B Heart Failure in the Emergency Department

The EMPOWER Trial - The Carillon Mitral Contour System® in Treating Heart Failure With at Least Mild FMR