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Clinical Data Validation of Novel Wireless Cortrium C3 Monitor for Continuous Electrocardiogram Measurements

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02714907
Recruitment Status : Completed
First Posted : March 22, 2016
Last Update Posted : January 27, 2020
Sponsor:
Collaborators:
University Hospital Bispebjerg and Frederiksberg
Aleris-Hamlet Hospitaler København
Information provided by (Responsible Party):
Cortrium

Brief Summary:
The purpose of this study is to validate the quality of the ECG-signal acquired with the Cortrium C3 monitor. The intention is to evaluate whether the diagnosis of atrial fibrillation based on the ECG signal from the C3 monitor concurs with the current monitoring methods used in clinical practice.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Device: Cortrium C3 device Device: Holter device Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 158 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Clinical Data Validation of Novel Wireless Cortrium C3 Monitor for Continuous Electrocardiogram Measurements
Study Start Date : February 2016
Actual Primary Completion Date : July 2017
Actual Study Completion Date : July 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: AF assessed from Cortrium C3 data
Atrial fibrillation assessed from Cortrium C3 device data
Device: Cortrium C3 device
Data is read from Cortrium C3 monitor

Device: Holter device
Date is read from Holter device

Experimental: AF assessed from Holter data
Atrial fibrillation assessed from Holter data
Device: Cortrium C3 device
Data is read from Cortrium C3 monitor

Device: Holter device
Date is read from Holter device




Primary Outcome Measures :
  1. Atrial fibrillation [ Time Frame: Through study completion, an average of 3 months ]
    Expert readings of long-term ECG reports to assess number of AF paroxysms.

  2. Heart rate (BPM) during atrial fibrillation [ Time Frame: Through study completion, an average of 3 months ]
    Expert readings of long-term ECG reports to assess heart rate in BPM.



Information from the National Library of Medicine

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

Inclusion Criteria:

  • Clinical diagnosis of atrial fibrillation
  • Investigation of atrial fibrillation

Exclusion Criteria:

  • Language difficulties
  • Impaired cognitive function.

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): NCT02714907


Locations
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Denmark
Department of Cardiology, Bispebjerg-Frederiksberg Hospitals
Frederiksberg, Denmark, 2000
Aleris-Hamlet Private Hospital
Soborg, Denmark, 2860
Sponsors and Collaborators
Cortrium
University Hospital Bispebjerg and Frederiksberg
Aleris-Hamlet Hospitaler København
Investigators
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Principal Investigator: Helena Helena, MD, PhD Bispebjerg-Frederiksberg Hospitals
Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site
In Danish language

Publications:
Fuster V, Rydén LE, Cannom DS, Crijns HJ, Curtis AB, Ellenbogen KA, Halperin JL, Le Heuzey JY, Kay GN, Lowe JE, Olsson SB, Prystowsky EN, Tamargo JL, Wann S; Task Force on Practice Guidelines, American College of Cardiology/American Heart Association; Committee for Practice Guidelines, European Society of Cardiology; European Heart Rhythm Association; Heart Rhythm Society. ACC/AHA/ESC 2006 guidelines for the management of patients with atrial fibrillation-executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the European Society of Cardiology Committee for Practice Guidelines (Writing Committee to Revise the 2001 Guidelines for the Management of Patients with Atrial Fibrillation). Eur Heart J. 2006 Aug;27(16):1979-2030. Erratum in: Eur Heart J. 2007 Aug;28(16):2046.

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Responsible Party: Cortrium
ClinicalTrials.gov Identifier: NCT02714907    
Other Study ID Numbers: H-15006113
First Posted: March 22, 2016    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes