Clinical trial NCT01559246: True Continuous ECG Monitoring (TCEM Study)
Official title: Comparison of Short Term Holter Monitoring vs. Long Term Zio(R)Patch True Continuous ECG Monitoring (TCEM Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Arrhythmia
Keywords: Cardiac Arrhythmia Monitoring
Holter Monitoring
Continuous ECG monitoring
Event monitoring
Observational
Lead sponsor: iRhythm Technologies, Inc.
Sponsor class: INDUSTRY
First posted: 2012-03-21
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients 18 years of age of greater with suspected arrhythmias.

Brief summary: 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.

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 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.

Primary outcomes:
measure: Arrhythmia detection for Zio® patch and the traditional ambulatory Holter monitor.
timeFrame: Up to 14 days.
Secondary outcomes:
measure: Subjects ease in comfort for the Zio® Patch and the traditional ambulatory Holter monitor.
timeFrame: Up to14 days.
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Scripps Health
state: California
Study officials:
affiliation: Scripps Translational Science Institute
name: Eric Topol, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Barrett PM, Komatireddy R, Haaser S, Topol S, Sheard J, Encinas J, Fought AJ, Topol EJ. Comparison of 24-hour Holter monitoring with 14-day novel adhesive patch electrocardiographic monitoring. Am J Med. 2014 Jan;127(1):95.e11-7. doi: 10.1016/j.amjmed.2013.10.003. Epub 2013 Oct 15.