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

Sponsor

LivaNova (Industry)

Overall Status

Suspended

CT.gov ID

NCT05975931

Collaborator

OPEN VIE Limited (Other)

229

Enrollment

Location

58.3

Anticipated Duration (Months)

3.9

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Epilepsy

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).

Study Design

Study Type:

Observational

Anticipated Enrollment :

229 participants

Observational Model:

Other

Time Perspective:

Retrospective

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.

Actual Study Start Date :

Jan 20, 2022

Anticipated Primary Completion Date :

Dec 1, 2024

Anticipated Study Completion Date :

Dec 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Cohort 1 ("new insertions cohort") Subjects who have had Aspire SR® implanted as their first VNS model.
Cohort 2 ("battery change cohort") Subjects who have had their VNS battery changed from a previous model to Aspire SR®.

Outcome Measures

Primary Outcome Measures

Descriptive comparison of healthcare resource use (HCRU) [24 months before and after device implantation]
Descriptive comparison of secondary HCRU in the 24 month periods before and after AspireSR® device implantation

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.