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

Baxter Healthcare Corporation109 enrolled

Overview

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

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

109

Conditions

Heart Failure Hypertension

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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.

Locations (1)

Imperial Cardiac Center

Imperial, California, United States

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

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