A Study to Determine the Feasibility of Wireless Electrocardiography
NCT02162394 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 14
Last updated 2017-09-25
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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