True Continuous ECG Monitoring (TCEM Study)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
iRhythm Technologies, Inc.
ClinicalTrials.gov Identifier:
NCT01559246
First received: March 9, 2012
Last updated: November 5, 2012
Last verified: November 2012
  Purpose

The purpose of this study is to compare short term (up to 48 hours) traditional cardiac rhythm monitoring using a standard ambulatory Holter monitor versus long term (up to 14 days), continuous ambulatory cardiac rhythm monitoring using a new device cleared by the FDA (Zio® Patch), iRhythm Technologies, Inc., San Francisco CA) in patients with suspected cardiac arrhythmias.


Condition
Cardiac Arrhythmia

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Comparison of Short Term Holter Monitoring vs. Long Term Zio(R)Patch True Continuous ECG Monitoring (TCEM Study)

Resource links provided by NLM:


Further study details as provided by iRhythm Technologies, Inc.:

Primary Outcome Measures:
  • Arrhythmia detection for Zio® patch and the traditional ambulatory Holter monitor. [ Time Frame: Up to 14 days. ] [ Designated as safety issue: No ]
    Data will be examined to determine the difference in the number of 6 types of arrhythmias detected at maximum observation times of 14 days and 24 hours respectively. In comparing the difference of the number of arrhythmias for the Zio® Patch and the Holter data, we are expecting a skewed distribution of the differences and will use a paired Wilcoxon Signed Rank Test since the normality assumption is not met for a paired t-test. If the difference is significantly greater than zero, there is evidence that the Zio® Patch is an improvement in this sample.


Secondary Outcome Measures:
  • Subjects ease in comfort for the Zio® Patch and the traditional ambulatory Holter monitor. [ Time Frame: Up to14 days. ] [ Designated as safety issue: No ]
    Subjects will be given surveys to complete at different time points. Surveys to include questions assessing subjects preference in devices. McNemar's Test will be used to examine if the responses for ease of wear was different between the Zio® Patch and the Holter. Comparing both devices when the Holter is returned in the first 24/48 hours, and comparing the Holter at 24/48 hours and the Zio® Patch at total observation (up to 14 days). McNemar's Test will be used to compare if the patient would use the Zio® Patch again and if they would use the Holter.


Estimated Enrollment: 150
Study Start Date: April 2012
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Cardiac Arrhythmia
Subjects 18 years of age or greater that have indications for traditional cardiac(Holter) monitoring.

Detailed Description:

This is a prospective, observational study of patients seen in the Holter lab at Scripps Green Hospital and other Scripps Clinic locations. Only patients who have indications for traditional cardiac rhythm monitoring will be enrolled in the study. Patients 18 years or older with suspected arrhythmias capable of providing informed consent will wear both a traditional Holter monitor for up to 48 hours and a Zio® Patch for up to 14 days. Both devices will be initiated at the same time as they do not interfere with one another. This will also allow a direct comparison of the same initial up to 24 hour monitoring period between the two devices. As the Zio® Patch is worn for up to 14 days instead of only 24 hours, it will be assessed if in the physician's opinion (referring physician), waiting for the extended time hinders being able to provide medical care and/or diagnosis for the patient.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patients 18 years of age of greater with suspected arrhythmias.

Criteria

Inclusion Criteria:

  • Are being seen in the outpatient office for evaluation, treatment, or follow-up of arrhythmias;
  • Have a medical history for which ascertaining whether asymptomatic arrhythmias is occurring could be helpful in their treatment plan;
  • Are capable of giving informed consent; assessed by the investigator or the Study Coordinator;
  • Are 18 years of age or older;
  • Able to comply with long term continuous monitoring ECG device.

Exclusion Criteria:

  • Have known skin allergies, conditions, or sensitivities (e.g. allergy to adhesives, psoriasis) as the Zio(R)Patch should not be used on patients with known skin allergies, conditions, or sensitivities; or
  • Are receiving pacing therapy (e.g., from a pacemaker); or
  • Are anticipated to receive or require external cardiac defibrillation during the monitoring period; or
  • Are anticipated to be exposed to high frequency surgical equipment during the monitoring period.
  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: NCT01559246

Locations
United States, California
Scripps Health
La Jolla, California, United States, 92037
Sponsors and Collaborators
iRhythm Technologies, Inc.
Investigators
Principal Investigator: Eric Topol, MD Scripps Translational Science Institute
  More Information

No publications provided by iRhythm Technologies, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: iRhythm Technologies, Inc.
ClinicalTrials.gov Identifier: NCT01559246     History of Changes
Other Study ID Numbers: iRT-001-2012
Study First Received: March 9, 2012
Last Updated: November 5, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by iRhythm Technologies, Inc.:
Cardiac Arrhythmia Monitoring
Holter Monitoring
Continuous ECG monitoring
Event monitoring
Observational

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

ClinicalTrials.gov processed this record on October 20, 2014