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

Completed

• Conditions: Heart Failure

• Registration Number: NCT02719301
• Lead Sponsor: Baxter Healthcare Corporation

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.

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2016-03-17
• Study First Submitted QC: 2016-03-24
• Study First Posted: 2016-03-25
• Primary Completion: 2017-01
• Study Completion: 2017-01
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-30
• Last Update Posted: 2017-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 85

Inclusion Criteria

• Must be able to undergo Cardiac MRI

Exclusion Criteria

• Sensitivity to electrodes

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison of Stroke Volume Measurement from Necklace with Cardiac MRI measurement of Stroke Volume	Retrospective up to 6 months after study completion