ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study to Determine the Feasibility of Wireless Electrocardiography

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02162394
Recruitment Status : Completed
First Posted : June 12, 2014
Last Update Posted : September 25, 2017
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment
Atrial Fibrillation Premature Atrial and Ventricular Beats Conduction Defects Normal Sinus Rhythm Device: Observational ambulatory ECG monitoring

Study Type : Observational
Actual Enrollment : 14 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study to Determine the Feasibility of Wireless Electrocardiography
Study Start Date : June 2014
Actual Primary Completion Date : April 2015
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. Percent of 8 second ECG strips of sufficient quality for visual diagnosis [ Time Frame: 3 hours ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects referred for 24 hour Holter monitoring
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02162394


Locations
United States, New York
Lenox Hill Hospital
New York, New York, United States, 10075
Sponsors and Collaborators
Peerbridge Health, Inc

Responsible Party: Peerbridge Health, Inc
ClinicalTrials.gov Identifier: NCT02162394     History of Changes
Other Study ID Numbers: 14-022A
First Posted: June 12, 2014    Key Record Dates
Last Update Posted: September 25, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes