QuantaFlo HD Clinical Validation Study

Semler Scientific

Status: Enrolling

Conditions: To Assess Cardiovascular Function

Treatments: Device: QuantaFlo HD

Study type: Observational

Funder types: Industry

Identifiers

NCT07219693

35-0262-01

Details and patient eligibility

About

The primary aim of this validation protocol is to assess cardiovascular function through transthoracic echocardiography ("Echo") measurements and the QuantaFlo HD test measuring blood flow at the finger during a forced expiration ("FE"). The study examines whether Echo-measured GLS values greater than -16% correlate with abnormal responses during FE as measured by QuantaFlo HD.

Enrollment: 600 estimated patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and female adult (≥ age 22) subjects with a minimum of 1 of the following:
• A history of Cardiovascular Diseasei or PAD
• Recorded history of at least two of the following
• Hypertension
• Diabetes
• Hyperlipidemia

Exclusion criteria

• Unable to safely perform a forced expiration, or unable to obtain a technically adequate FE test result
• Subjects with a pacemaker or ICD with pacemaker function
• Terminal advanced illness
• Recent cardiothoracic surgery (within 12 months)
• Retinal eye disease with anticoagulants
• History of eye surgery, within 90 days
• Uncontrolled hypertension >180 mmHg systolic pressure or >100 mmHg diastolic pressure
• Subjects with severe tremors