Necklace-Shaped Sensor for Non-Invasive Monitoring of Stroke Volume and Cardiac Output

Completed

Phase N/A Results N/A

Trial Description

Study will compare measurements made with Necklace device for stroke volume/cardiac output with values from a FDA-approved reference device. The gold standard that will be used is Cardiac MRI. Subjects will be measured with both the Necklace, reference device, and the Cardiac MRI. Values calculated by the Cardiac MRI analysis will be compared with the reference device and the Necklace.

Detailed Description

Study will compare measurements made with Necklace device for stroke volume/cardiac output with values from a FDA-approved reference device. The gold standard that will be used is Cardiac MRI. Subjects will be measured with both the Necklace, reference device, and the Cardiac MRI. Values calculated by the Cardiac MRI analysis will be compared with the reference device and the Necklace.
The Cardiac MRI will be received ~1-4 days after the measurement is completed. The data will be compared with data collected from the Necklace and the reference device during the study.

Conditions

Trial Design

  • Observation: Cohort
  • Perspective: Retrospective
  • Sampling: Non-Probability Sample

Trial Population

Men and Women between 18 and 85.

Outcomes

Type Measure Time Frame Safety Issue
Primary Comparison of Stroke Volume Measurement from Necklace with Cardiac MRI measurement of Stroke Volume Retrospective up to 6 months after study completion No

Sponsors