A Study to Determine the Feasibility of Wireless Electrocardiography

September 20, 2017 updated by: Peerbridge Health, Inc

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

14

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10075
        • Lenox Hill Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects referred for 24 hour Holter monitoring

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Referred for Holter monitoring
Device: Observational ambulatory ECG monitoring

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent of 8 second ECG strips of sufficient quality for visual diagnosis
Time Frame: 3 hours
3 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peerbridge Health, Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

June 10, 2014

First Submitted That Met QC Criteria

June 11, 2014

First Posted (Estimate)

June 12, 2014

Study Record Updates

Last Update Posted (Actual)

September 25, 2017

Last Update Submitted That Met QC Criteria

September 20, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-022A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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