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OpenTrials
Completed

NCT Number: NCT02337790

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

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

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases Hypertension Vascular Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Imperial Cardiac Center

Imperial, California, 92251, United States

About this study

The study had the following objectives:

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Baxter Healthcare Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jan 14, 2015
Registry last updated
Dec 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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