Clinical trial NCT05975931: IMPACT of AspireSR® for VNS Therapy on Healthcare Resource Utilisation and Clinical Outcomes.
Official 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.
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Epilepsy
Keywords: VNS
Drug Resistant Epilepsy
Vagus Nerve Stimulation
AspireSR®
Health Care Utilization
DRE
Lead sponsor: LivaNova
Sponsor class: INDUSTRY
Collaborators: name: OPEN VIE Limited
First posted: 2023-08-04
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male and female adult (aged ≥18 years at AspireSR® implantation) subjects with epilepsy who have had the VNS device AspireSR® implanted at least 24 months prior to study retrospective data collection.

Brief summary: This is a retrospective non-interventional study to describe the HCRU and clinical outcomes before and after AspireSR® device implantation in subjects with drug resistant epilepsy at the Queen Elizabeth Hospital, Birmingham (QEHB).

Detailed description: Real-world data on healthcare resource use (HCRU) for subjects with treatment-resistant epilepsy and their clinical outcome prior to- and post-VNS device implantation in the UK are limited.

The current study aims to describe and compare the secondary HCRU and clinical outcomes prior to and following AspireSR® device implantation in subjects with drug resistant epilepsy.

Retrospectively-collected data from hospital medical records (paper-based and/or electronic, as appropriate) will be used to describe subject characteristics, disease control and clinical outcomes. All secondary HCRU data will be extracted from the Hospital Episode Statistics (HES) database by Harvey Walsh Ltd (HW, trading under OPEN VIE). Primary HCRU data will be requested from the subjects' general practitioners (GPs).

Eligibility criteria: Inclusion Criteria:

* Age ≥18 years at AspireSR® device implantation.
* VNS device AspireSR® implantation for the first time or battery change from a previous model to AspireSR® at least 24 months prior to the start of retrospective data collection from medical records.
* Subjects for whom written informed consent has been provided for researcher access to their medical records and extraction of data from HES (if the subject is living and has capacity to consent) or advice from a consultee (if the subject is living but lacks capacity to consent).
* Subjects with available medical history for at least 24 months prior to Aspire SR® implantation.

Exclusion Criteria:

* Living subjects for whom consent for researcher access to medical records and extraction of data from HES has not been obtained.
* Deceased subjects.

Primary outcomes:
measure: Descriptive comparison of healthcare resource use (HCRU)
timeFrame: 24 months before and after device implantation
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: Queen Elizabeth Hospital Birmingham
Study officials:
affiliation: The Queen Elizabeth Hospital
name: Barbara Wysota
role: PRINCIPAL_INVESTIGATOR
References: