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

Epilepsy Clinical Trial

— IMPACT  

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.

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT05975931
• Other study ID #: LNE802
• Status: Suspended
• Start date: January 20, 2022
• Est. completion date: December 2026

Study information

• Verified date: July 2023
• Source: LivaNova
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 229
• Est. completion date: December 2026
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Epilepsy

Locations

Country	Name	City	State
United Kingdom	Queen Elizabeth Hospital Birmingham	Birmingham

Sponsors (2)

Lead Sponsor	Collaborator
LivaNova	OPEN VIE Limited

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Descriptive comparison of healthcare resource use (HCRU)	Descriptive comparison of secondary HCRU in the 24 month periods before and after AspireSR® device implantation	24 months before and after device implantation