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

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ClinicalTrials.gov Identifier: NCT03657134
Recruitment Status : Recruiting
First Posted : September 3, 2018
Last Update Posted : January 14, 2019
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Ventricular Tachycardia Diagnostic Test: CoVa 2 Sensor Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Introductory Clinical Trial for Measuring Patients Before, During, and After an Electrophysiology (EP) Procedure With a Novel, Body-Worn Sensor
Actual Study Start Date : November 15, 2018
Estimated Primary Completion Date : December 15, 2019
Estimated Study Completion Date : December 15, 2019


Arm Intervention/treatment
Experimental: EP Procedure
Patient will continuously wear the CoVa TM 2 system until they are discharged for period of about 24 hours. 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 Sensor
Upon completion of EP procedure, CoVa 2 sensor will be applied until discharge. Data from the sensor will be sent to the Gateway and Cloudbased system and analyzed retrospectively.




Primary Outcome Measures :
  1. Time to Discharge [ Time Frame: 1 Week ]
    Number of days patients spend in hospital post surgery



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03657134


Contacts
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Contact: Oksana Tatarina-Nulman 212 263 5555 Larry.Chinitz@nyumc.org

Locations
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United States, New York
New York University School of Medicine Recruiting
New York, New York, United States, 10016
Contact: Oksana Tatarina    212-263-5555    oksana.tatarinanulman@nyumc.org   
Principal Investigator: Larry Chinitz, MD         
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Larry Chinitz NYU Langone Health

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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT03657134     History of Changes
Other Study ID Numbers: 17-01618
First Posted: September 3, 2018    Key Record Dates
Last Update Posted: January 14, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Atrial Fibrillation
Tachycardia
Tachycardia, Ventricular
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Cardiac Conduction System Disease