True Continuous ECG Monitoring (TCEM Study)

Completed

Conditions studied: Cardiac Arrhythmia

In brief

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.

Key facts

Study ID

NCT01559246

Run by

iRhythm Technologies, Inc.

People needed

150

Starts

2012-04-01

Expected to finish

2012-12-01

Last updated by the study team

2019-04-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

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.

Where it is running

• Scripps Health — La Jolla, California, United States

Full record on ClinicalTrials.gov

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