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

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiac Conduction System Disease Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Tachycardia Tachycardia, Ventricular Ventricular Tachycardia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York University School of Medicine

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CoVa-2 Monitoring System

Diagnostic Test

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.

Primary outcomes

Average Change in Heart Rate (HR)

Time frame: Baseline, 8 Hours

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.
Average Change in Respiratory Rate (RR)

Time frame: Baseline, 8 Hours

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.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Important dates

Study start: 2018
Primary completion: 2020
Study completion: 2020
First posted: Sep 4, 2018
Registry last updated: Sep 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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