IMPACT: Non-interventional study of Aspire SR® VNS device
Research type
Research Study
Full title
A single-centre, non-interventional, retrospective study to describe the IMPACT of AspireSR® for vagus nerve stimulation (VNS) therapy on healthcare resource utilisation and clinical outcomes.
IRAS ID
282649
Contact name
Barbara Wysota
Contact email
Sponsor organisation
LivaNova
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
This is a single centre, non-interventional retrospective study to describe the impact of AspireSR® for vagus nerve stimulation (VNS) therapy on healthcare resource utilisation (HCRU) and clinical outcomes in adult subjects with epilepsy.
Epilepsy causes seizures and affects about 70 million people worldwide. Drug treatments for epilepsy often fail to control seizures and this places a burden on patients and the healthcare system. VNS, delivered by an implanted device, is an approved adjunctive (additional or supplementary) treatment. AspireSR® is a relatively new type of VNS device that was developed by a company called LivaNova. A recent UK study showed that a reduction in the number and burden of seizures was achieved for subjects receiving AspireSR®. Another study has shown that AspireSR® VNS is better than Demipulse, a previous VNS device.
Real-world data for this patient population on HCRU and clinical outcomes before and after VNS device implantation are limited. This study aims to fill this knowledge gap.
Up to 229 subjects will be recruited from Queen Elizabeth Hospital (QEB), Birmingham, UK.
Adult patients (age ≥18 years at AspireSR® implantation) will take part. They must have medical history records available for at least 24 months prior to at AspireSR® implantation, for data collection.
Eligible subjects will be allocated to one of two cohorts: Cohort 1 New insertions (subjects with AspireSR® implanted as their first VNS device); Cohort 2 Battery change (subjects with VNS battery change from a previous model to AspireSR®).
Retrospective data on subject demographics and clinical outcomes will be collected from QEB medical records by a member of the direct care team or a researcher.
Secondary HCRU, including HCRU outside of QEB, will be obtained from the Hospital Episode Statistics database. Primary HCRU data will be requested from the subject’s GPs by the lead clinician by letter.REC name
Wales REC 2
REC reference
20/WA/0310
Date of REC Opinion
6 Dec 2020
REC opinion
Further Information Favourable Opinion