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

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.

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.

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.