A Study to Determine the Feasibility of Wireless Electrocardiography

NCT02162394 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 14

Last updated 2017-09-25

No results posted yet for this study

Summary

The investigators are conducting a prospective, observational study to examine the ECG waveforms captured by the new medical device as compared to a traditional Holter monitor for subsequent use in visual diagnoses of atrial and ventricular arrhythmias as well as cardiac impulse and/or conduction disorders by qualified clinicians.

The hypothesis is that this new medical device prototype is non-inferior to traditional Holter monitoring for capturing ECG waveforms that can be visually assessed for atrial and ventricular arrhythmias as well as disorders of cardiac impulse formation and/or conduction.

Conditions

  • Atrial Fibrillation
  • Premature Atrial and Ventricular Beats
  • Conduction Defects
  • Normal Sinus Rhythm

Interventions

DEVICE

Observational ambulatory ECG monitoring

Sponsors & Collaborators

  • Peerbridge Health, Inc

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2015-04-30
Completion
2016-01-31

Countries

  • United States

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 NCT02162394 on ClinicalTrials.gov