ECG Vector Determination

ECG Vector Determination for Model 106 Generator Implant Site Selection

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01486056

Enrollment

Registered

2011-12-06

Start date

2011-11-30

Completion date

2012-01-31

Last updated

2012-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsy

Keywords

epilepsy, ECG, device placement

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

12 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
To correlate ECG amplitude with prospective VNS implant sites.	up to 2 days	This study is designed to collect ECG data to determine the process for proper generator and lead placement.

Secondary

Measure	Time frame
To identify potential VNS implant sites associated with low ECG amplitudes.	up to 2 days

Countries

United States

Outcome results