ECG Vector Determination

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cyberonics, Inc.
ClinicalTrials.gov Identifier:
NCT01486056
First received: November 28, 2011
Last updated: August 20, 2012
Last verified: August 2012
  Purpose

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


Condition
Epilepsy

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: ECG Vector Determination for Model 106 Generator Implant Site Selection

Resource links provided by NLM:


Further study details as provided by Cyberonics, Inc.:

Primary Outcome Measures:
  • To correlate ECG amplitude with prospective VNS implant sites. [ Time Frame: up to 2 days ] [ Designated as safety issue: No ]
    This study is designed to collect ECG data to determine the process for proper generator and lead placement.


Secondary Outcome Measures:
  • To identify potential VNS implant sites associated with low ECG amplitudes. [ Time Frame: up to 2 days ] [ Designated as safety issue: No ]

Enrollment: 29
Study Start Date: November 2011
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
healthy patients, may have epilepsy
Subjects at least 12 years old and in general good health for Phase I, and at least 18 years old and in general good health for Phase II. It is desired, but not required, for subjects to have epilepsy and taking at least 1 antiepileptic medication.

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

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01486056

Locations
United States, Texas
Clinical Trials of Texas, Inc.
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Cyberonics, Inc.
Investigators
Principal Investigator: Douglas Denham, DO Clinical Trails of Texas, Inc.
Study Director: Bryan Olin, Ph.D Cyberonics, Inc.
  More Information

Publications:
Responsible Party: Cyberonics, Inc.
ClinicalTrials.gov Identifier: NCT01486056     History of Changes
Other Study ID Numbers: E-35
Study First Received: November 28, 2011
Last Updated: August 20, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Cyberonics, Inc.:
epilepsy
ECG
device placement

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on October 23, 2014