Necklace-Shaped Sensor for Non-Invasive Monitoring of Stroke Volume, Cardiac Output, Fluids, Heart Rate, Heart Rate Variability, and Respiration Rate
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Heart Failure
- Sponsor
- Baxter Healthcare Corporation
- Enrollment
- 85
- Primary Endpoint
- Comparison of Stroke Volume Measurement from Necklace with Cardiac MRI measurement of Stroke Volume
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Must be able to undergo Cardiac MRI
Exclusion Criteria
- •Sensitivity to electrodes
Outcomes
Primary Outcomes
Comparison of Stroke Volume Measurement from Necklace with Cardiac MRI measurement of Stroke Volume
Time Frame: Retrospective up to 6 months after study completion