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

NCT02714907 | Completed DMC

• 1 other identifier: H-15006113
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 2

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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

• Atrial fibrillation

  Expert readings of long-term ECG reports to assess number of AF paroxysms.

  Through study completion, an average of 3 months

• Heart rate (BPM) during atrial fibrillation

  Expert readings of long-term ECG reports to assess heart rate in BPM.

  Through study completion, an average of 3 months

Study Arms (2)

AF assessed from Cortrium C3 data

EXPERIMENTAL

Atrial fibrillation assessed from Cortrium C3 device data

Device: Cortrium C3 device; Device: Holter device

AF assessed from Holter data

EXPERIMENTAL

Atrial fibrillation assessed from Holter data

Device: Cortrium C3 device; Device: Holter device

Interventions

Cortrium C3 device DEVICE

Data is read from Cortrium C3 monitor

AF assessed from Cortrium C3 data; AF assessed from Holter data

Holter device DEVICE

Date is read from Holter device

AF assessed from Cortrium C3 data; AF assessed from Holter data

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of atrial fibrillation
• Investigation of atrial fibrillation

You may not qualify if:

• Language difficulties
• Impaired cognitive function.

Sponsors & Collaborators

• Cortrium: lead
• University Hospital Bispebjerg and Frederiksberg: collaborator
• Aleris-Hamlet Hospitaler København: collaborator

Study Sites (2)

Department of Cardiology, Bispebjerg-Frederiksberg Hospitals

Frederiksberg, 2000, Denmark

Location

Aleris-Hamlet Private Hospital

Søborg, 2860, Denmark

Location

Related Publications (21)

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MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Helena Helena, MD, PhD

  Bispebjerg-Frederiksberg Hospitals

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2016
• First Posted: March 22, 2016
• Study Start: February 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: January 27, 2020

Record last verified: 2020-01

Locations

DK (2)