NCT03657134

Introductory Clinical Trial for Measuring Patients Before, During, and After an Electrophysiology (EP) Procedure With a Novel, Body-Worn Sensor

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Subjects will be consented to wear the CoVa-2 monitoring system prior to (baseline), during, and after an Electrophysiology Procedure (EP). During this time, the system will measure the following parameters from subjects: heart rate (HR), Heart Rate Variability (HRV), respiration rate (RR), and Cardiac Output (CO). Data will be retrospectively analyzed to determine if the system effectively operates under these conditions, and can effectively monitor subjects and allow them to be discharged early from the hospital. Subjects will not be measured while transferred in and out of the operating room. Approximate sample size is 20 subjects.

Conditions

• Atrial Fibrillation
• Ventricular Tachycardia

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	CoVa-2 Monitoring System	Upon completion of EP procedure, CoVa-2 monitoring system will be applied until discharge. Data from the sensor will be sent to the Gateway and Cloud-based system and analyzed retrospectively.

Timeline

• Start date: 2018-11-15
• Primary completion: 2020-07-28
• Completion: 2020-07-28
• First posted: 2018-09-04
• Last updated: 2021-09-22
• Results posted: 2021-09-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study