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

NCT ID: NCT02719301

Last Updated: 2017-07-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

85 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-09-30

Study Completion Date

2017-01-31

Brief Summary

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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

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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

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Heart Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Men/Women between 18 & 85

Accepting both healthy and non-healthy subjects. A portion of the subjects will have a fluid management issue or heart failure.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Must be able to undergo Cardiac MRI

Exclusion Criteria

* Sensitivity to electrodes
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Baxter Healthcare Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Matthew J Banet

Role: PRINCIPAL_INVESTIGATOR

Baxter Healthcare Corporation

Other Identifiers

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PERM-IRB-001-CM

Identifier Type: -

Identifier Source: org_study_id

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