Registry of Subjects With Drug Resistant Epilepsy and Treated With the VNS Therapy System. (CORE-VNS)

LivaNova

Status

Active, not recruiting

Conditions

Seizures

Drug Resistant Epilepsy

Epilepsy

Treatments

Device: Vagus Nerve Stimulation (VNS) Therapy

Study type

Observational

Funder types

Industry

Identifiers

NCT03529045

LNN-801

Details and patient eligibility

About

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

Full 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.

Enrollment

2,000 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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.