IMPACT of AspireSR® for VNS Therapy on Healthcare Resource Utilisation and Clinical Outcomes.

LivaNova

Status: Terminated

Conditions: Epilepsy

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT05975931

LNE802

Details and patient eligibility

About

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).

Full 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).

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

15 participants in 2 patient groups

Cohort 1 ("new insertions cohort")

Description:

Subjects who have had Aspire SR® implanted as their first VNS model.

Cohort 2 ("battery change cohort")

Description:

Subjects who have had their VNS battery changed from a previous model to Aspire SR®.