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

Study Overview
=================
Brief 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.

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

Conditions
-----------------
Atrial Fibrillation, Ventricular Tachycardia

Intervention / Treatment
-----------------
* Diagnostic Test: CoVa-2 Monitoring System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with arrhythmias and other cardiac conditions that are scheduled for EP procedures. Subject is over 22 years of age at the time of consenting Subject and/or legally authorized representative is willing to undergo the informed consent process prior to enrollment in the study Exclusion Criteria: Pregnant subjects Subjects who are participating in another clinical study that may affect the results of either study Subjects who are unwilling or unable to wear the sensor (and electrodes) for a period of up to 14 hours Subjects who are considered by the principle investigator to be medically unsuitable for study participation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EP Procedure<br>Patient will continuously wear the CoVa-2 monitoring system until they are discharged. During this period, data from the sensor will be sent to the Gateway and Cloud-based System, and then analyzed retrospectively. | Diagnostic Test: CoVa-2 Monitoring System<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Change in Heart Rate (HR) | HR data is retrospectively analyzed from the CoVa-2 monitoring system, and the average change in HR (prior to the start of EP (baseline) to completion of EP (8 hours)) is reported. | Baseline, 8 Hours | 
| Average Change in Respiratory Rate (RR) | RR data is retrospectively analyzed from the CoVa-2 monitoring system, and the average change in RR (prior to the start of EP (baseline) to completion of EP (8 hours)) is reported. | Baseline, 8 Hours |