A Study to Determine the Feasibility of Wireless Electrocardiography

NCT02162394 | Completed DMC

• 1 other identifier: 14-022A
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

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

  3 hours

Study Arms (1)

Referred for Holter monitoring

Device: Observational ambulatory ECG monitoring

Interventions

Observational ambulatory ECG monitoring DEVICE

Referred for Holter monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects referred for 24 hour Holter monitoring

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peerbridge Health, Inc: lead

Study Sites (1)

Lenox Hill Hospital

New York, New York, 10075, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation; Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2014
• First Posted: June 12, 2014
• Study Start: June 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: January 1, 2016
• Last Updated: September 25, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)