ECG Vector Determination

Completed

Conditions studied: Epilepsy

In brief

This is a prospective, unblinded, non-randomized, descriptive study designed to collect ECG data.

Key facts

Study ID

NCT01486056

Run by

Cyberonics, Inc.

People needed

29

Starts

2011-11-01

Expected to finish

2012-01-01

Last updated by the study team

2012-08-21

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• At least 12 years old and in general good health for Phase I. At least 18 years old and in general good health for Phase II.
• Patients or their guardians must be willing to provide signed informed consent/assent and HIPAA authorization. Note: Patients diagnosed with epilepsy and taking at least 1 antiepileptic medication are desired but not required for the study.

You may not qualify if…

• History of pathologically significant cardiac arrhythmias including but not limited to atrial fibrillation or flutter, chronotropic incompetence, supraventricular tachycardia, ventricular flutter or fibrillation, or implantation of a permanent cardiac pacemaker or defibrillator.
• Currently present existing signs of skin irritation or rash on the left neck or upper left chest as determined by the PI.
• History of physical adverse reaction to adhesive electrodes.

Where it is running

• Clinical Trials of Texas, Inc. — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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