NCT02337790

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 109 (actual)
• Sponsor: Baxter Healthcare Corporation · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Heart Failure
• Hypertension

Timeline

• Start date: 2015-01-01
• Primary completion: 2015-05-01
• Completion: 2015-05-01
• First posted: 2015-01-14
• Last updated: 2015-12-30

Locations

1 site across 1 country: United States