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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02719301
• Other study ID #: PERM-IRB-001-CM
• Status: Completed
• Phase: N/A
• First received: March 17, 2016
• Last updated: June 30, 2017
• Start date: September 2015
• Est. completion date: January 2017

Study information

• Verified date: June 2017
• Source: toSense, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Must be able to undergo Cardiac MRI

Exclusion Criteria:

• Sensitivity to electrodes

Related Conditions & MeSH terms

• Heart Failure

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
toSense, Inc.

Outcome

Type	Measure	Description	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