A 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Conduction Defects Heart Diseases Normal Sinus Rhythm Pathologic Processes Pathological Conditions, Signs and Symptoms Premature Atrial and Ventricular Beats

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Lenox Hill Hospital

New York, 10075, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Observational ambulatory ECG monitoring

Device

Primary outcomes

Percent of 8 second ECG strips of sufficient quality for visual diagnosis

Time frame: 3 hours

Sponsors and collaborators

Lead sponsor

Peerbridge Health, Inc

Industry

Registry information

Official study title

Study to Determine the Feasibility of Wireless Electrocardiography

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2016
First posted: Jun 12, 2014
Registry last updated: Sep 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed