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

NYU Langone Health20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Atrial Fibrillation Ventricular Tachycardia

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients with arrhythmias and other cardiac conditions that are scheduled for EP procedures. 2. Subject is over 22 years of age at the time of consenting 3. Subject and/or legally authorized representative is willing to undergo the informed consent process prior to enrollment in the study Exclusion Criteria: 1. Pregnant subjects 2. Subjects who are participating in another clinical study that may affect the results of either study 3. Subjects who are unwilling or unable to wear the sensor (and electrodes) for a period of up to 14 hours 4. Subjects who are considered by the principle investigator to be medically unsuitable for study participation

Outcomes

Primary Outcomes

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.

Time frame: 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.