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OpenTrials
Completed

NCT Number: NCT02719301

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

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Must be able to undergo Cardiac MRI

Exclusion criteria

  • Sensitivity to electrodes

Treatment and study plan

Primary outcomes

  1. Comparison of Stroke Volume Measurement from Necklace with Cardiac MRI measurement of Stroke Volume

    Time frame: Retrospective up to 6 months after study completion

Sponsors and collaborators

Lead sponsor

Baxter Healthcare Corporation

Industry

Registry information

Official study title

Necklace-Shaped Sensor for Non-Invasive Monitoring of Stroke Volume, Cardiac Output, Fluids, Heart Rate, Heart Rate Variability, and Respiration Rate

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Mar 25, 2016
Registry last updated
Jul 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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