Study to Determine the Feasibility of Wireless Electrocardiography

Peerbridge Health, Inc1 site in 1 country14 target enrollmentJune 2014

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

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Atrial Fibrillation
Sponsor: Peerbridge Health, Inc
Enrollment: 14
Locations: 1
Primary Endpoint: Percent of 8 second ECG strips of sufficient quality for visual diagnosis
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 2014

End Date

January 2016

Last Updated

8 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Peerbridge Health, Inc

Responsible Party

Sponsor

Eligibility Criteria

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