A Study to Determine the Feasibility of Wireless Electrocardiography

Peerbridge Health

Status: Completed

Conditions: Atrial Fibrillation; Conduction Defects; Premature Atrial and Ventricular Beats; Normal Sinus Rhythm

Treatments: Device: Observational ambulatory ECG monitoring

Study type: Observational

Funder types: Industry

Identifiers

NCT02162394

14-022A

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

14 participants in 1 patient group

Referred for Holter monitoring

Treatment:

Device: Observational ambulatory ECG monitoring