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

NCT03657134 | Completed Results FDA Device

• 1 other identifier: 17-01618
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation; Ventricular Tachycardia

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

EP Procedure

EXPERIMENTAL

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

Interventions

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.

EP Procedure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation; Tachycardia, Ventricular

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Lior Jankelson, MD, PhD
• Organization: NYU Langone Health

Lior.Jankelson@nyulangone.org

212-263-7149

Study Officials

• Lior Jankelson, MD, PhD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2018
• First Posted: September 4, 2018
• Study Start: November 15, 2018
• Primary Completion: July 28, 2020
• Study Completion: July 28, 2020
• Last Updated: September 22, 2021
• Results First Posted: September 22, 2021

Record last verified: 2021-08

Locations

US (1)