Purpose

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

Category

IRB Number
20180684HU
NCT Number
NCT03529045
Open to Enrollment
Yes
Sponsor
LivaNova -



Study Contact

Local Recruitment Point of Contact
Linda Leary
2104500500
learyl@uthscsa.edu

Principal Investigator
Linda Leary

Regulatory Point of Contact
Linda Leary
2104500500
learyl@uthscsa.edu

Regulatory Point of Contact
Sarah Martinez
(210) 450-0569
martinezs23@uthscsa.edu

Regulatory Point of Contact
Charlotte Rhodes
(210) 450-8454
rhodesc1@uthscsa.edu



Eligibility

Eligible 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

Study Type
Observational [Patient Registry]
Observational Model
Cohort
Time Perspective
Prospective
Condition
  • Epilepsy
  • Seizures
  • Drug Resistant Epilepsy
  • Arm Groups

    ArmDescriptionIntervention

    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.