A Study to Determine the Feasibility of Wireless Electrocardiography

Atrial Fibrillation Clinical Trial

Official title:

Study to Determine the Feasibility of Wireless Electrocardiography

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02162394
• Other study ID #: 14-022A
• Status: Completed
• Phase: N/A
• First received: June 10, 2014
• Last updated: September 20, 2017
• Start date: June 2014
• Est. completion date: January 2016

Study information

• Verified date: September 2017
• Source: Peerbridge Health, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: January 2016
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Device:
• Observational ambulatory ECG monitoring

Locations

Country	Name	City	State
United States	Lenox Hill Hospital	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Peerbridge Health, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of 8 second ECG strips of sufficient quality for visual diagnosis		3 hours