A Post-Marketing Study for On Label Evaluation of the GE Vscan Ultrasound Imaging System

General Electric (GE)

Status: Completed

Conditions: Heart Valve Diseases; Right Ventricular Dysfunction; Left Ventricular Dysfunction; Pulmonary Hypertension

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01076296

OHSU_Vscan_02

Details and patient eligibility

About

This study is to collect data and learn more about the Vscan Ultrasound Imaging System. It is an "observational" study with no additional procedures or intervention prescribed other than using the Vscan along with a routine medical physical exam.

Full description

The study requires 2 visits to OHSU.

At the first visit a cardiac physical exam will be done by a cardiologist.

At a second visit, a different cardiologist will perform an ultrasound scan (as part of your standard of care) using a Vscan Ultrasound System. The first and the second visit may be done on the same day depending upon your schedule and if it's convenient for you to stay. The total exam time for both the visits, including standard exam and the study device exam will be about 45 minutes.

Enrollment: 1,000 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years or older
• provided signed and dated informed consent and is willing to provide GE Healthcare with demographic data, cardiac medical history, information collected as part of the study
• New patients who have an echocardiogram less than 6 months and patients who will be undergoing an echocardiogram as part of their routine clinical care

Exclusion criteria

• Pregnant
• less than 18 years of age.
• unwilling to provide informed Consent