ClinicalTrials.gg
CompletedNCT02162394Updated Sep 25, 2017

A Study to Determine the Feasibility of Wireless Electrocardiography

An observational study in Atrial Fibrillation, Premature Atrial and Ventricular Beats and Conduction Defects, sponsored by Peerbridge Health, Inc. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-09-25.

Sponsored by Peerbridge Health, Inc · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
14
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Atrial Fibrillation
  • Premature Atrial and Ventricular Beats
  • Conduction Defects
  • Normal Sinus Rhythm
03

In context

Atrial Fibrillation

4,009 studies on the registry are indexed under Atrial Fibrillation; 961 are open to participants now.

This study's enrollment of 14 is below the median of 300 across 1,400 observational studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

Peerbridge Health, Inc is the lead sponsor of 4 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Subjects referred for 24 hour Holter monitoring

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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
  • 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

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
  • Patients affected by inflammatory and/or infectious skin disorders
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
14 participants (actual)
Patient registry
No

Groups and cohorts

  • Referred for Holter monitoring

    Device: Observational ambulatory ECG monitoring

Interventions

  • DeviceObservational ambulatory ECG monitoring
06

What researchers measure

Primary outcomes

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

    Time frame: 3 hours

07

Study locations

1 site
  • Lenox Hill Hospital
    New York, New York 10075, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 25, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02162394
Lead sponsor
Peerbridge Health, Inc
Responsible party
Sponsor
First posted
Jun 12, 2014
Start date
Jun 2014
Primary completion
Apr 2015
Completion
Jan 2016
Last update
Sep 25, 2017

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion