A Study to Determine the Feasibility of Wireless Electrocardiography
Completed
Conditions studied: Atrial Fibrillation, Premature Atrial and Ventricular Beats, Conduction Defects, Normal Sinus Rhythm
In brief
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.
Key facts
- Study ID
- NCT02162394
- Run by
- Peerbridge Health, Inc
- People needed
- 14
- Starts
- 2014-06-01
- Expected to finish
- 2016-01-01
- Last updated by the study team
- 2017-09-25
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients must be at least 18 years of age
- Patients must have a medical indication to wear a Holter monitor
- Patients must not be pregnant
- Patients must be able to comply with the study procedures
- Patients must be willing to participate and able to provide informed consent
- Patients must be willing to wear both devices (Holter and the wireless device prototype) simultaneously and continuously for a 2 to 3 hr period
You may not qualify if…
- Patients who are not able or willing to comply with study procedures
- Patients with an existing implanted cardioverter-defibrillator and/or pacemaker
- Patients with a known life threatening arrhythmia
- Patients who manifest low voltage on their electrocardiogram
- Patients affected by inflammatory and/or infectious skin disorders
Where it is running
- Lenox Hill Hospital — New York, New York, United States
Full record on ClinicalTrials.gov
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