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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03657134
• Other study ID #: 17-01618
• Status: Completed
• Phase: N/A
• Start date: November 15, 2018
• Est. completion date: July 28, 2020

Study information

• Verified date: August 2021
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 28, 2020
• Est. primary completion date: July 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Tachycardia
• Tachycardia, Ventricular
• Ventricular Tachycardia

Intervention

Diagnostic Test:
• CoVa-2 Monitoring System
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.

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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