Atrial Fibrillation, Conduction Defects, Normal Sinus Rhythm, Premature Atrial and Ventricular Beats
Conditions
Brief 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.
Interventions
DEVICEObservational ambulatory ECG monitoring
Sponsors
Peerbridge Health, Inc
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent of 8 second ECG strips of sufficient quality for visual diagnosis | 3 hours |
Countries
United States
Outcome results
None listed