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



Status:Recruiting
Conditions:Atrial Fibrillation, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 100
Updated:1/16/2019
Start Date:November 15, 2018
End Date:December 15, 2019
Contact:Oksana Tatarina-Nulman
Email:Larry.Chinitz@nyumc.org
Phone:212 263 5555

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Trial Summary
Trial Overview
Inclusion Criteria
Subjects will be consented to wear the CoVa TM 2 prior to, during, and after an
Electrophysiology Procedure. 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.


Inclusion Criteria:

- Males and females over 18 years of age undergoing a RF ablation of AF or VT at NYU
Langone Medical Center.

Exclusion Criteria:

- Women who are pregnant at the time of procedure.
We found this trial at
1
site
New York University School of Medicine
550 1st Ave
New York, New York 10016
(212) 263-7300
Principal Investigator: Larry Chinitz, MD
Phone: 212-263-5555
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