CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 20 enrolled
Drug / intervention
CoVa-2 Monitoring Systemother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03657134
NCT03657134N/ACompleted
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Introductory Clinical Trial for Measuring Patients Before, During, and After an Electrophysiology (EP) Procedure With a Novel, Body-Worn Sensor

NYU Langone Health·interventional·Posted Sep 4, 2018·Updated Sep 22, 2021

In Brief

A clinical study evaluating CoVa-2 Monitoring System for Atrial Fibrillation and Ventricular Tachycardia. Completed, enrolled 20 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtrial Fibrillation, Ventricular Tachycardia
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedSep 4, 2018
Enrollment StartNov 15, 2018
Primary CompletionJul 28, 2020
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 7.8 years ago

Interventions

CoVa-2 Monitoring Systemother

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.