Status:
TERMINATED
IMPACT of AspireSR® for VNS Therapy on Healthcare Resource Utilisation and Clinical Outcomes.
Lead Sponsor:
LivaNova
Collaborating Sponsors:
OPEN VIE Limited
Conditions:
Epilepsy
Eligibility:
All Genders
18+ years
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 Elizabe...
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 curre...
Eligibility Criteria
Inclusion
- 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
- Living subjects for whom consent for researcher access to medical records and extraction of data from HES has not been obtained.
- Deceased subjects.
Key Trial Info
Start Date :
January 20 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 30 2024
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT05975931
Start Date
January 20 2022
End Date
January 30 2024
Last Update
December 3 2024
Active Locations (1)
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1
Queen Elizabeth Hospital Birmingham
Birmingham, United Kingdom