A Study to Determine the Feasibility of Wireless Electrocardiography

Peerbridge Health, Inc14 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

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

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

A Study to Determine the Feasibility of Wireless Electrocardiography

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes