True Continuous ECG Monitoring (TCEM Study)

NCT01559246 | Completed

• 1 other identifier: iRT-001-2012
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Arrhythmia

Keywords

Cardiac Arrhythmia Monitoring; Holter Monitoring; Continuous ECG monitoring; Event monitoring; Observational

Outcome Measures

Primary Outcomes (1)

• Arrhythmia detection for Zio® patch and the traditional ambulatory Holter monitor.

  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.

  Up to 14 days.

Secondary Outcomes (1)

• Subjects ease in comfort for the Zio® Patch and the traditional ambulatory Holter monitor.

  Up to14 days.

Study Arms (1)

Cardiac Arrhythmia

Subjects 18 years of age or greater that have indications for traditional cardiac(Holter) monitoring.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients 18 years of age of greater with suspected arrhythmias.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• iRhythm Technologies, Inc.: lead

Study Sites (1)

Scripps Health

La Jolla, California, 92037, United States

Location

Related Publications (1)

• 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.

  PMID: 24384108 DERIVED

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Eric Topol, MD

  Scripps Translational Science Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2012
• First Posted: March 21, 2012
• Study Start: April 1, 2012
• Primary Completion: November 1, 2012
• Study Completion: December 1, 2012
• Last Updated: April 18, 2019

Record last verified: 2019-04

Locations

US (1)