Purpose

Multicenter global post-market registry of subjects diagnosed with drug resistant epilepsy and treated with the VNS Therapy System.

Conditions

Eligibility

Eligible Ages
All ages
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Clinical diagnosis of drug resistant epilepsy treated with VNS Therapy. Eligible subjects include those not previously treated with VNS Therapy as well as subjects receiving replacement generators.
  • Able and willing to comply with the frequency of study visits.
  • Subject, or legal guardian, understands study procedures and voluntarily signs an informed consent in accordance with institutional policies. In the event that the subject is under the age of 18, the subject may also be required (per EC/IRB) to sign an assent affirming their agreement to participate.

Exclusion Criteria

• There are no exclusion criteria in this study. Investigators should refer to the local instructions for use for VNS Therapy.

Study Design

Phase
Study Type
Observational [Patient Registry]
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
VNS Therapy Any approved VNS Therapy System (according to local regulations) may be used in this registry.
  • Device: Vagus Nerve Stimulation (VNS) Therapy
    The VNS Therapy System is a commercially available device that will be used by licensed medical practitioners trained in the use of VNS Therapy, per the practitioners' medical judgement.

Recruiting Locations

University of Texas Health Science Center at San Antonio
San Antonio, Texas 78229
Contact:
Floyd Jones
jonesfa@uthscsa.edu

More Details

NCT ID
NCT03529045
Status
Recruiting
Sponsor
LivaNova

Study Contact

Wim Van Grunderbeek
+32 2 245 40 67
Wim.Vangrunderbeek@livanova.com

Detailed Description

The purpose of this registry is to evaluate clinical outcome and safety data in subjects with drug resistant epilepsy treated with the VNS Therapy System. The study will collect outcomes for subjects treated with VNS Therapy in a real-world setting.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.