A Study to Determine the Feasibility of Wireless Electrocardiography
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Atrial Fibrillation, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/2/2016 |
| Start Date: | June 2014 |
| Contact: | Nicholas Skipitaris, MD |
| Phone: | 212-434-6500 |
Study to Determine the Feasibility of Wireless Electrocardiography
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.
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.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
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