The Simple ECG Monitoring Trial (Comparison of a Novel Recording System With a Standard Holter Monitor)

NCT01382953 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2012-01-10

No results posted yet for this study

Summary

The purpose of this research is to simplify the standard recording system of the heart rhythm. The investigators desire to improve the ease of monitoring the cardiac rhythm for 24 hours. The investigators intent is to use a very small, innovative monitoring patch system that relieves the patient of wearing a cumbersome and uncomfortable recording system. This research trial will carry the title "The Simple ECG Monitoring" for Comparison of a Sternal ECG Recording System with a Standard ECG Recording System for Holter Monitoring. The data from the investigational device is for comparative purposes only. It will not be used by medical personnel for study subject treatment or diagnostic purposes.

Conditions

Interventions

DEVICE

Standard Holter/Investigational patch

The standard Holter and Investigational patch will be worn simultaneously for 24 hours. A single follow-up visit will follow in 2 days to remove both systems which will be sent away for analysis with the results of the standard system used, if pertinent, for patient management.

Sponsors & Collaborators

  • Cardiac Science Corporation.

    collaborator UNKNOWN
  • Seattle Institute for Cardiac Research

    lead OTHER

Principal Investigators

  • Gust H. Bardy, MD · Seattle Institute for Cardiac Research

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2011-10-31
Completion
2011-10-31

Countries

  • United States
  • New Zealand

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01382953 on ClinicalTrials.gov