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A Non-interventional Study Describing the Healthcare Resource Utilisation and Clinical Outcomes Associated With LivaNova Vagus Nerve Stimulation Therapy in the UK. (DANTE)

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ClinicalTrials.gov Identifier: NCT04779814
Recruitment Status : Not yet recruiting
First Posted : March 3, 2021
Last Update Posted : March 3, 2021
Sponsor:
Collaborator:
OPEN VIE Limited
Information provided by (Responsible Party):
LivaNova

Study Description
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Brief Summary:
This is a UK, multi-center, non-interventional study based on the use of health service administrative and medical records (paper-based and/or electronic, as applicable) along with the use of prospectively collected subject-reported outcomes on experience with use of VNS therapy using validated and bespoke self-completion questionnaires. Data for hospital resource utilisation will be extracted from the Hospital Episode Statistics (HES) database.

Condition or disease
Epilepsy

Detailed Description:
Failure to control seizures in subjects with treatment resistant epilepsy can have a significant burden on the healthcare system. Vagus Nerve Stimulation (VNS) is an adjunctive treatment for patients with drug resistant epilepsy and is reported to reduce the frequency of seizures in adults and children. However, real-world data on healthcare resource utilization by patients with treatment-resistant epilepsy and their clinical outcomes prior to and post VNS device implantation in the UK are limited. The current study aims to describe the resource utilization and clinical outcomes prior to and following the implantation of different VNS devices (Demipulse®/Aspire HC®, Aspire SR® and SenTiva®) in subjects with drug resistant epilepsy
Study Design
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Study Type : Observational
Estimated Enrollment : 180 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: A Non-interventional Study Describing the Healthcare Resource Utilisation and Clinical Outcomes Associated With LivaNova Vagus Nerve Stimulation Therapy in the UK.
Estimated Study Start Date : March 2021
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

Groups and Cohorts
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Group/Cohort
Cohort 1
Demipulse®/Aspire HC® (30 adult subjects)
Cohort 2
Demipulse®/Aspire HC® (30 pediatric subjects)
Cohort 3
Aspire SR® (30 adult subjects)
Cohort 4
Aspire SR® (30 pediatric subjects)
Cohort 5
SenTiva® (30 adult subjects)
Cohort 6
SenTiva® (30 pediatric subjects)


Outcome Measures
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Primary Outcome Measures :
  1. Change in hospital resource utilization [ Time Frame: Change from 12-month pre- implantation of VNS device to 18-month post-implantation of VNS device ]
    To describe the change in hospital resource utilization from the 12-month period pre- to the 18-month period post-implantation of VNS device in subjects with drug resistant epilepsy.


Secondary Outcome Measures :
  1. Change in Seizure information using ILAE classification [ Time Frame: Change from 12-month pre- implantation of VNS device to 6-month, to 12-month and to 18-month post-implantation of VNS device ]
    Onset and current classification and any prior classification of seizures will be described using ILAE classification

  2. Initial titration period for each VNS device [ Time Frame: 18-month period post-implantation of VNS device. ]
  3. Characteristics and demographics of subjects at the time of implantation of VNS Therapy. [ Time Frame: Implant procedure ]
  4. Change of AED treatments [ Time Frame: Change from 12-month pre- implantation of VNS device to 18-month post-implantation of VNS device ]
    Assess the change in anti-epileptic drugs including dose change

  5. Change in Seizure severity; using measures such as rescue medication and/or time to recovery. [ Time Frame: Change from 12-month pre- implantation of VNS device to 6-month, to 12-month and to 18-month post-implantation of VNS device ]
  6. Change in Seizure frequency (by seizure type*, if available) and any changes in frequency. [ Time Frame: Change from 12-month pre- implantation of VNS device to 6-month, to 12-month and to 18-month post-implantation of VNS device ]
  7. Change in frequency of status epilepticus. [ Time Frame: Change from 12-month pre- implantation of VNS device to 6-month, to 12-month and to 18-month post-implantation of VNS device ]

Eligibility Criteria
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Ages Eligible for Study:   1 Year and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Male and female adult (aged ≥16 years at VNS implantation) and paediatric (aged 1-15 years at VNS implantation) subjects with epilepsy who have had a VNS device Demipulse®/Aspire HC®, Aspire SR® or SenTiva® implanted will be involved in this study.
Criteria

Inclusion Criteria:

Living subjects who meet all of the following criteria will be considered for enrolment:

  • Clinical diagnosis of drug resistant epilepsy
  • Subjects who have had their first VNS device (Demipulse®/Aspire HC®, Aspire SR® and SenTiva®) implanted at least 18 months prior to their enrolment in the study data (with no change in generator, battery or lead).
  • For SenTiva® and Aspire SR®, AutoStim was first activated within 1 month of implantation.
  • For SenTiva®, scheduled dosing mode was activated within 1 month of implantation.
  • Subjects must be able and willing to provide informed consent; subjects aged 7-12 years old and 13-15 years old will be provided with appropriate information and consent forms to explain the study in age appropriate language. These subjects will be asked to provide their assent to take part in the study, with consent provided by their parent/carer. Subjects under 7 years will be included in the study with consent from their parent/carer. For adult subjects (≥16 years) lacking the mental capacity to consent, advice about participation will be sought from an appropriate consultee, according to the Mental Capacity Act 2005.
  • Adult and paediatric subjects (aged over 2.5 years at study enrolment) with available medical records for at least 12 months prior to VNS device implantation.

Exclusion Criteria:

  • Subjects whose medical records are not available for review.
  • Deceased subjects.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04779814


Contacts
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Contact: Jo Hough 44 (0) 7714 771 214 johough@openvie.com

Sponsors and Collaborators
LivaNova
OPEN VIE Limited
Investigators
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Principal Investigator: Mike Carter Bristol Royal Hospital for Children
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: LivaNova
ClinicalTrials.gov Identifier: NCT04779814    
Other Study ID Numbers: LNE801
First Posted: March 3, 2021    Key Record Dates
Last Update Posted: March 3, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by LivaNova:
VNS
DRE
drug resistant epilepsy
Vagus Nervus Stimulation
Healthcare Resource Utilization
Additional relevant MeSH terms:
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Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases