Registry of Subjects With Drug Resistant Epilepsy and Treated With the VNS Therapy System.



Status:Recruiting
Conditions:Neurology, Neurology, Epilepsy
Therapuetic Areas:Neurology, Other
Healthy:No
Age Range:Any
Updated:3/27/2019
Start Date:February 5, 2018
End Date:March 31, 2027
Contact:Wim Van Grunderbeek
Email:Wim.Vangrunderbeek@livanova.com
Phone:+32 2 245 40 67

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CORE-VNS: Comprehensive Outcomes Registry in Subjects With Epilepsy Treated With Vagus Nerve Stimulation Therapy

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

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.

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.
We found this trial at
4
sites
Winchester, Virginia 22604
Principal Investigator: Paul Lyons
Phone: 540-536-6518
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Brisbane,
Principal Investigator: Kate Rinet, Dr.
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Brisbane,
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Honolulu, Hawaii 96817
Principal Investigator: Kore Liow, MD
Phone: 808-564-6142
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Honolulu, HI
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Tampa, Florida 33609
Principal Investigator: Jose Ferreira
Phone: 813-873-7367
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Tampa, FL
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