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

Completed

Conditions studied: Heart Diseases

In brief

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)

Key facts

Study ID

NCT05104307

Run by

Stephen Esper

People needed

79

Starts

2021-11-09

Expected to finish

2024-01-02

Last updated by the study team

2024-05-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• UPMC Montefiore Hospital — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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