Status:
COMPLETED
ECG Vector Determination
Lead Sponsor:
Cyberonics, Inc.
Conditions:
Epilepsy
Eligibility:
All Genders
12+ years
Brief Summary
This is a prospective, unblinded, non-randomized, descriptive study designed to collect ECG data.
Detailed Description
This is a prospective, unblinded, non-randomized, descriptive study designed to collect ECG data and determine the process for proper generator and lead placement. The study will be conducted in two p...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
November 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT01486056
Start Date
November 1 2011
End Date
January 1 2012
Last Update
August 21 2012
Active Locations (1)
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1
Clinical Trials of Texas, Inc.
San Antonio, Texas, United States, 78229