A Study to Determine the Feasibility of Wireless Electrocardiography

Completed

• Conditions: Atrial Fibrillation; Conduction Defects; Normal Sinus Rhythm; Premature Atrial and Ventricular Beats
• Interventions: Device: Observational ambulatory ECG monitoring

• Registration Number: NCT02162394
• Lead Sponsor: Peerbridge Health, Inc

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-06-10
• Study First Submitted QC: 2014-06-11
• Study First Posted: 2014-06-12
• Primary Completion: 2015-04
• Study Completion: 2016-01
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-20
• Last Update Posted: 2017-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Referred for Holter monitoring	Observational ambulatory ECG monitoring	-

Primary Outcome Measures

Name	Time	Method
Percent of 8 second ECG strips of sufficient quality for visual diagnosis	3 hours

Trial Locations

Locations (1)

Lenox Hill Hospital; 🇺🇸 New York, New York, United States