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A Study to Determine the Feasibility of Wireless Electrocardiography

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2014 by Peerbridge Health, Inc
Sponsor:
Information provided by (Responsible Party):
Peerbridge Health, Inc
ClinicalTrials.gov Identifier:
NCT02162394
First received: June 10, 2014
Last updated: June 11, 2014
Last verified: June 2014
  Purpose

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 Intervention
Cardiac Rhythm Disturbances Including:
Atrial Fibrillation
Premature Atrial and Ventricular Beats
Conduction Defects
Normal Sinus Rhythm
Device: Observational ambulatory ECG monitoring

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study to Determine the Feasibility of Wireless Electrocardiography

Resource links provided by NLM:


Further study details as provided by Peerbridge Health, Inc:

Primary Outcome Measures:
  • Percent of 8 second ECG strips of sufficient quality for visual diagnosis [ Time Frame: 3 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: June 2014
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Referred for Holter monitoring Device: Observational ambulatory ECG monitoring

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02162394

Contacts
Contact: Nicholas Skipitaris, MD 212-434-6500

Locations
United States, New York
Lenox Hill Hospital Not yet recruiting
New York, New York, United States, 10075
Principal Investigator: Nicholas Skipitaris, MD         
Sponsors and Collaborators
Peerbridge Health, Inc
  More Information

No publications provided

Responsible Party: Peerbridge Health, Inc
ClinicalTrials.gov Identifier: NCT02162394     History of Changes
Other Study ID Numbers: 14-022A
Study First Received: June 10, 2014
Last Updated: June 11, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 20, 2014