Necklace-Shaped Sensor for Non-Invasive Remote Monitoring of Vitals

December 28, 2015 updated by: Baxter Healthcare Corporation

Necklace-Shaped Sensor for Non-Invasive Monitoring of Fluids, Heart Rate, Heart Rate Variability, and Respiration Rate in Patients With a Pacemaker, Implanted Cardioverter-Defibrillator, or Ventricular Assist Device

This study is designed to validate the use of the CoVa Monitoring System in subjects with implanted devices.

Study Overview

Status

Completed

Conditions

Detailed Description

The study had the following objectives:

  1. Verify that the CoVa Monitoring System does not interfere with implanted devices.
  2. Verify that implanted devices do not interfere with the functions of the CoVa Monitoring System.
  3. Verify that the CoVa Monitoring System fits on a wide variety of body types.

Study Type

Observational

Enrollment (Actual)

109

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Imperial, California, United States, 92251
        • Imperial Cardiac Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects will be from the Imperial Cardiac Clinic

Description

Inclusion Criteria:

  • Subject is between 21 (twenty-one) and 95 (ninety-five) years of age at screening.
  • Subject has a pacemaker, implanted cardioverter-defibrillator, or ventricular assist device.
  • Subject and/or legally authorized person/representative is willing to undergo the Informed Consent process prior to enrollment in the study.
  • Subject is a candidate for this study based on the PI's opinion and knowledge of the subject's condition.

Exclusion Criteria:

  • Subject is participating in another clinical study that may affect the results of either study.
  • Subject is unable or not willing to wear electrode patches as required.
  • Subject has skin sensitivity to adhesive or hydrogel materials used in electrode patches.
  • Subject is considered by the PI to be medically unsuitable for study participation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Cohort 1
Subjects will have a pacemaker, implanted cardioverter-defibrillator, or ventricular assist device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Patients with Interference between implanted devices and CoVa Monitoring System
Time Frame: One time for up to 15 minutes during a clinic visit for device interrogation
One time for up to 15 minutes during a clinic visit for device interrogation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baxter Healthcare Corporation

Investigators

  • Principal Investigator: Matthew J Banet, PhD, Baxter Healthcare Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

January 9, 2015

First Submitted That Met QC Criteria

January 13, 2015

First Posted (Estimate)

January 14, 2015

Study Record Updates

Last Update Posted (Estimate)

December 30, 2015

Last Update Submitted That Met QC Criteria

December 28, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PERM-IRB-001-ICC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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