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

Baxter Healthcare Corporation1 site in 1 country109 target enrollmentJanuary 2015

ConditionsHeart Failure Hypertension

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Heart Failure
Sponsor: Baxter Healthcare Corporation
Enrollment: 109
Locations: 1
Primary Endpoint: Number of Patients with Interference between implanted devices and CoVa Monitoring System
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

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.

Registry

clinicaltrials.gov

Start Date

January 2015

End Date

May 2015

Last Updated

10 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Baxter Healthcare Corporation

Responsible Party

Sponsor

Eligibility Criteria

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.