Clinical trial NCT01486056: ECG Vector Determination
Official title: ECG Vector Determination for Model 106 Generator Implant Site Selection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epilepsy
Keywords: epilepsy
ECG
device placement
Lead sponsor: Cyberonics, Inc.
Sponsor class: INDUSTRY
First posted: 2011-12-06
Enrollment: 29
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects 12 years and older in general good health, preferably with epilepsy and on at least 1 antiepileptic medication.

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 phases: Phase I includes ECG data collection from human subjects; Phase II, the Implant Instructions for Use will be evaluated by Cyberonics' Clinical Engineers based on the activities of five to eight experienced VNS surgeons.

Eligibility criteria: Inclusion Criteria:

1. 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.
2. 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 Criteria:

1. 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.
2. Currently present existing signs of skin irritation or rash on the left neck or upper left chest as determined by the PI.
3. History of physical adverse reaction to adhesive electrodes.

Primary outcomes:
measure: To correlate ECG amplitude with prospective VNS implant sites.
timeFrame: up to 2 days
Secondary outcomes:
measure: To identify potential VNS implant sites associated with low ECG amplitudes.
timeFrame: up to 2 days
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Clinical Trials of Texas, Inc.
state: Texas
Study officials:
affiliation: Clinical Trails of Texas, Inc.
name: Douglas Denham, DO
role: PRINCIPAL_INVESTIGATOR
affiliation: Cyberonics, Inc.
name: Bryan Olin, Ph.D
role: STUDY_DIRECTOR
References:
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