Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03529045
Recruitment Status : Recruiting
First Posted : May 18, 2018
Last Update Posted : April 24, 2020
Sponsor:
Information provided by (Responsible Party):
LivaNova

Tracking Information
First Submitted Date February 22, 2018
First Posted Date May 18, 2018
Last Update Posted Date April 24, 2020
Actual Study Start Date February 5, 2018
Estimated Primary Completion Date December 31, 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 20, 2019)
  • Seizure Frequency [ Time Frame: Baseline, 3, 6, 12, 24, and 36 months after implant; long term follow-up data through 60 months may be collected, if applicable ]
    The average seizure frequency per month over the last 3 months (by type) will be collected
  • Maximum Seizure Free Period [ Time Frame: Baseline, 3, 6, 12, 24, and 36 months after implant; long term follow-up data through 60 months may be collected, if applicable ]
    The maximum seizure free period over the last 3 months will be collected
  • Seizure Severity [ Time Frame: Baseline, 3, 6, 12, 24, and 36 months after implant; long term follow-up data through 60 months may be collected, if applicable ]
    Seizure severity is a categorical outcome and will be rated by the subject using the following categories: Very mild, Mild, Moderate, Severe, Very Severe
  • Post-ictal Severity [ Time Frame: Baseline, 3, 6, 12, 24, and 36 months after implant; long term follow-up data through 60 months may be collected, if applicable ]
    Seizure severity is a categorical outcome and will be rated by the subject using the following categories: Very mild, Mild, Moderate, Severe, Very Severe
  • Change in Quality of Life [ Time Frame: Baseline, 3, 6, 12, 24, and 36 months after implant; long term follow-up data through 60 months may be collected, if applicable ]
    Quality of life is a categorical outcome and will be rated by the subject using the following categories: Very good: could hardly be better, Pretty good, Good and bad parts about equal, Pretty bad, Very bad: could hardly be worse
  • Quality of Sleep [ Time Frame: Baseline, 3, 6, 12, 24, and 36 months after implant; long term follow-up data through 60 months may be collected, if applicable ]
    Quality of sleep will be reported using the Pittsburgh Sleep Quality Index for subjects 18 years and older and using the Children's Sleep Habit Questionnaire for subjects 2-17 years old; quality of sleep will not be assessed in children under 2 years old
  • Anti-epileptic Drug Use [ Time Frame: Baseline, 3, 6, 12, 24, and 36 months after implant; long term follow-up data through 60 months may be collected, if applicable ]
    The name and dose of anti-epileptic drugs used will be collected on a case report form
  • Rescue Drug Use [ Time Frame: Baseline, 3, 6, 12, 24, and 36 months after implant; long term follow-up data through 60 months may be collected, if applicable ]
    The number of times a rescue drug was used will be collected
  • Seizure Related Emergency Department Visits [ Time Frame: Baseline, 3, 6, 12, 24, and 36 months after implant; long term follow-up data through 60 months may be collected, if applicable ]
    The number of times a patient had a seizure related emergency department (ED) visit will be collected
  • Seizure Related Hospitalizations [ Time Frame: Baseline, 3, 6, 12, 24, and 36 months after implant; long term follow-up data through 60 months may be collected, if applicable ]
    The number of times a patient had a seizure related inpatient hospitalization and the length of each stay will be collected
Original Primary Outcome Measures
 (submitted: May 7, 2018)
  • Seizure Frequency [ Time Frame: Baseline, 3, 6, 12, 24, and 36 months after implant; long term follow-up data through 60 months may be collected, if applicable ]
    The average seizure frequency per month over the last 3 months (by type) will be collected
  • Maximum Seizure Free Period [ Time Frame: Baseline, 3, 6, 12, 24, and 36 months after implant; long term follow-up data through 60 months may be collected, if applicable ]
    The maximum seizure free period over the last 3 months will be collected
  • Seizure Severity [ Time Frame: Baseline, 3, 6, 12, 24, and 36 months after implant; long term follow-up data through 60 months may be collected, if applicable ]
    Seizure severity is a categorical outcome and will be rated by the subject using the following categories: Very mild, Mild, Moderate, Severe, Very Severe
  • Post-ictal Severity [ Time Frame: Baseline, 3, 6, 12, 24, and 36 months after implant; long term follow-up data through 60 months may be collected, if applicable ]
    Seizure severity is a categorical outcome and will be rated by the subject using the following categories: Very mild, Mild, Moderate, Severe, Very Severe
  • Quality of Life [ Time Frame: Baseline, 3, 6, 12, 24, and 36 months after implant; long term follow-up data through 60 months may be collected, if applicable ]
    Quality of life is a categorical outcome and will be rated by the subject using the following categories: Very good: could hardly be better, Pretty good, Good and bad parts about equal, Pretty bad, Very bad: could hardly be worse
  • Quality of Sleep [ Time Frame: Baseline, 3, 6, 12, 24, and 36 months after implant; long term follow-up data through 60 months may be collected, if applicable ]
    Quality of sleep will be reported using the Pittsburgh Sleep Quality Index for subjects 18 years and older and using the Children's Sleep Habit Questionnaire for subjects 2-17 years old; quality of sleep will not be assessed in children under 2 years old
  • Anti-epileptic Drug Use [ Time Frame: Baseline, 3, 6, 12, 24, and 36 months after implant; long term follow-up data through 60 months may be collected, if applicable ]
    The name and dose of anti-epileptic drugs used will be collected on a case report form
  • Rescue Drug Use [ Time Frame: Baseline, 3, 6, 12, 24, and 36 months after implant; long term follow-up data through 60 months may be collected, if applicable ]
    The number of times a rescue drug was used will be collected
  • Seizure Related Emergency Department Visits [ Time Frame: Baseline, 3, 6, 12, 24, and 36 months after implant; long term follow-up data through 60 months may be collected, if applicable ]
    The number of times a patient had a seizure related emergency department (ED) visit will be collected
  • Seizure Related Hospitalizations [ Time Frame: Baseline, 3, 6, 12, 24, and 36 months after implant; long term follow-up data through 60 months may be collected, if applicable ]
    The number of times a patient had a seizure related inpatient hospitalization and the length of each stay will be collected
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Registry of Subjects With Drug Resistant Epilepsy and Treated With the VNS Therapy System.
Official Title CORE-VNS: Comprehensive Outcomes Registry in Subjects With Epilepsy Treated With Vagus Nerve Stimulation Therapy
Brief Summary Multicenter global post-market registry of subjects diagnosed with drug resistant epilepsy and treated with the VNS Therapy System.
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.
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 5 Years
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Subjects diagnosed with drug resistant epilepsy and treated with the VNS Therapy System. Eligible subjects include those receiving VNS Therapy for the first time, as well as those that are being re-implanted with VNS
Condition
  • Epilepsy
  • Seizures
  • Drug Resistant Epilepsy
Intervention 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.
Study Groups/Cohorts VNS Therapy
Any approved VNS Therapy System (according to local regulations) may be used in this registry.
Intervention: Device: Vagus Nerve Stimulation (VNS) Therapy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 7, 2018)
2000
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 31, 2027
Estimated Primary Completion Date December 31, 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.

Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: Wim Van Grunderbeek +32 2 715 93 12 Wim.Vangrunderbeek@livanova.com
Contact: Leann Speering Leann.Speering@livanova.com
Listed Location Countries Australia,   Austria,   Belgium,   Canada,   China,   India,   Israel,   Italy,   Japan,   Netherlands,   Poland,   Portugal,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03529045
Other Study ID Numbers LNN-801
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party LivaNova
Study Sponsor LivaNova
Collaborators Not Provided
Investigators
Study Director: Jason Jones, MS LivaNova USA, Inc.
PRS Account LivaNova
Verification Date April 2020