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CompletedNCT02337790Updated Dec 30, 2015

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

An observational study in Heart Failure and Hypertension, sponsored by Baxter Healthcare Corporation. Completed at 1 site in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2015-12-30.

Sponsored by Baxter Healthcare Corporation · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
109
Ages
18 Years to 90 Years
Sex
All
01

Study summary

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

Read the 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.
02

Conditions studied

  • Heart Failure
  • Hypertension

Keywords

  • Hypertension
  • Heart Failure
  • Fluids
03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's enrollment of 109 is below the median of 210 across 1,359 observational studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Baxter Healthcare Corporation is the lead sponsor of 78 studies on the registry; 1 is open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 3 (30%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Subjects will be from the Imperial Cardiac Clinic

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

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.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
109 participants (actual)
Patient registry
No

Groups and cohorts

  • Cohort 1

    Subjects will have a pacemaker, implanted cardioverter-defibrillator, or ventricular assist device.

06

What researchers measure

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

07

Study locations

1 site
  • Imperial Cardiac Center
    Imperial, California 92251, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 30, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02337790
Lead sponsor
Baxter Healthcare Corporation
Responsible party
Sponsor
First posted
Jan 14, 2015
Start date
Jan 2015
Primary completion
May 2015
Completion
May 2015
Last update
Dec 30, 2015

Study contacts

Matthew J Banet, PhD
principal investigator · Baxter Healthcare Corporation

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.

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