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

Not Applicable

Completed

• Conditions: Atrial Fibrillation; Ventricular Tachycardia
• Interventions: Diagnostic Test: CoVa-2 Monitoring System

• Registration Number: NCT03657134
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-08-08
• Study First Submitted QC: 2018-08-29
• Study First Posted: 2018-09-04
• Study Start: 2018-11-15
• Primary Completion: 2020-07-28
• Study Completion: 2020-07-28
• Status Verified: 2021-08
• Results First Submitted: 2021-08-02
• Results First Submitted QC: 2021-08-26
• Last Update Submitted: 2021-08-26
• Results First Posted: 2021-09-22
• Last Update Posted: 2021-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EP Procedure	CoVa-2 Monitoring System	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.

Primary Outcome Measures

Name	Time	Method
Average Change in Respiratory Rate (RR)	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.
Average Change in Heart Rate (HR)	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.

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States