NCT03657134|CompletedResultsFDA Device
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Sponsor study identifier
interventional
20
1 country
1
Study Start
November 15, 2018
Actual (reported)Primary Completion
July 28, 2020
Actual (reported)Study Completion
July 28, 2020
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 28, 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 8, 2018
Actual (reported)September 4, 2018
Actual (reported)November 15, 2018
Actual (reported)July 28, 2020
Actual (reported)July 28, 2020
Actual (reported)September 22, 2021
Actual (reported)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
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.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
New York University School of Medicine
New York, New York, 10016, United States
Lior Jankelson, MD, PhD
NYU Langone Health
20 participants (actual enrollment reported by the registry).
First Submitted
August 8, 2018
First Posted
September 4, 2018
Study Start
November 15, 2018
Actual (reported)Initial Management of Patients Receiving a Single Shock (IMPRESS)
Contact the study team to confirm eligibility.
Primary Completion
July 28, 2020
Actual (reported)Study Completion
July 28, 2020
Actual (reported)Last Updated
September 22, 2021
Results First Posted
September 22, 2021
Record last verified: 2021-08
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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