DANTE:Non-interventional study of implanted VNS devices in epilepsy
Research type
Research Study
Full title
A Non-interventional Study Describing the Healthcare Resource Utilisation and Clinical Outcomes Associated with LivaNova Vagus Nerve Stimulation Therapy in the UK.
IRAS ID
281076
Contact name
Michael Carter
Contact email
Sponsor organisation
Liva Nova
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
CURRENTLY 296 WORDS (MAX ALLOWED 300)
This is a UK multi-centre non-interventional study describing the healthcare resource utilisation and clinical outcomes associated with vagus nerve stimulation therapy in patients with treatment-resistant epilepsy.
Epilepsy causes seizures and affects about 70 million people worldwide. First and second line treatments may fail to control seizures in about 30% of patients which places a significant burden on the healthcare system. Vagus nerve stimulation (VNS), delivered by an implantable device is an approved adjunctive (additional or supplemental) treatment. Meta-analysis of clinical studies indicates a reduction of seizures following VNS therapy. However, real-world data on healthcare resource utilisation by patients in this population and their clinical outcomes in the UK are limited. The current study aims to address this knowledge gap by collecting and analysing data prior to- and post- implantation of different VNS devices (Demipulse®/Aspire HC®, Aspire SR® and SenTiva®) manufactured by LivaNova, a medical technology company.
Patients diagnosed with drug resistant epilepsy who have had their first VNS device for at least 18 months will take part. Retrospective resource data (e.g. A&E attendances, non-elective or elective hospital admissions) will be collected from the Hospital Episode Statistics (HES) database. Retrospective data on subject demographics and characteristics, clinical outcomes and VNS titration will be collected from hospital medical records. Prospective data will be collected by using questionnaires completed by subjects or their parent carers, as applicable.
Up to 150-180 subjects (adults and children aged over 2.5 years at enrolment) at three to four specialist hospitals in England will enter the study in 1 of 6 cohorts.
• LivaNova Demipulse®/Aspire HC® - Cohort 1 30 adult subjects; Cohort 2 30 paediatric subjects.
• LivaNova Aspire SR® - Cohort 3 30 adult subjects; Cohort 4 30 paediatric subjects.
• LivaNova SenTiva® - Cohort 5 30 adult subjects; Cohort 6 30 paediatric subjects.REC name
Wales REC 4
REC reference
20/WA/0320
Date of REC Opinion
10 Dec 2020
REC opinion
Favourable Opinion