Necklace-Shaped Sensor for Non-Invasive Remote Monitoring of Vitals
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02337790|
Recruitment Status : Completed
First Posted : January 14, 2015
Last Update Posted : December 30, 2015
|Condition or disease|
|Heart Failure Hypertension|
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.
|Study Type :||Observational|
|Actual Enrollment :||109 participants|
|Official 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|
|Study Start Date :||January 2015|
|Actual Primary Completion Date :||May 2015|
|Actual Study Completion Date :||May 2015|
Subjects will have a pacemaker, implanted cardioverter-defibrillator, or ventricular assist device.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02337790
|United States, California|
|Imperial Cardiac Center|
|Imperial, California, United States, 92251|
|Principal Investigator:||Matthew J Banet, PhD||toSense, Inc.|