Aortic stenosis Circulatory System
Conditions
Interventions
Current interventions as of 04/10/2024:
The study is an RCT evaluating use of the cerebral embolic protection device (Sentinel, Boston Scientific) in participants with aortic valve stenosis planned
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 04/11/2021: 1. Participant is willing and able to give informed consent for participation in the trial 2. Aged 18 years or above 3. Considered to be candidates for TAVI by the clinical team (via any access route where CEP may be used) 4. Participant is suitable for treatment with the cerebral embolic protection device in the opinion of the treating physician Previous inclusion criteria: 1. Willing and able to give informed consent for participation in the trial. 2. Aged 18 years or above 3. Diagnosed with aortic stenosis (including bioprosthetic valve dysfunction) 4. Planned transfemoral TAVI
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 04/11/2021: No specific exclusion criteria. Participants involved in observational studies will be eligible for this study. As this is an all-comer design, current or previous participation in other ongoing randomised trials will not be disqualifying for recruitment to this study unless treatment is expected to impact the effect of using a CEP device on stroke. _____ Previous exclusion criteria: 1. Anatomically unsuitable for treatment with the cerebral embolic protection device in the opinion of the treating physician 2. Clinical contra-indications to the use of the CEP device in the opinion of the treating physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 20/02/2025: The incidence of stroke at 72 hours post-TAVI, or hospital discharge (if sooner). Events will be validated by an independent clinical events committee blinded to trial treatment. _____ Previous primary outcome measure as of 04/11/2021: The incidence of stroke at 72 hours post-TAVI, or hospital discharge (if sooner). Events will be assessed by the local stroke team and validated by an independent clinical events committee blinded to trial treatment. _____ Previous primary outcome measure: The incidence of all stroke within 72 hours (or hospital discharge) of the TAVI procedure, measured using patient records | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 04/10/2024: 1.Combined incidence of all-cause mortality or non-fatal stroke at 72 hours post-TAVI or hospital discharge (if sooner) 2. Combined incidence of all-cause mortality, non-fatal stroke or transient ischaemic attack at 72 hours post-TAVI or hospital discharge (if sooner). 3. Incidence of all-cause mortality at 72 hours post-TAVI or hospital discharge (if sooner) 4. Win ratio for all-cause mortality, disabling stroke and non-disabling stroke at 72 hours post-TAVI, or hospital discharge (if sooner) 5.Incidence of all-cause mortality at 12 months post-TAVI. 6. Incidence of all-cause mortality up to the end of the trial. This will use trial data up to 12 months, and centrally held NHS data from 12 months to the end of the trial 7. Incidence of stroke as defined by centrally held NHS data between 72 hours post-TAVI or hospital discharge (if sooner) and 30-days post-TAVI. 8. Incidence of stroke as defined by centrally held NHS data between 30-days post-TAVI and the end of the trial. 9. Stroke Severity: Assessed using the National Institutes of Health Stroke Scale (NIHSS) in participants who have had a stroke within 72-hours post-TAVI or hospital discharge (if sooner) 10. Disability Outcome Assessed using the Simple Modified Rankin Scale questionnaire (smRSq) up to 12 months post-TAVI in participants who have had a stroke within 72-hours post-TAVI or hospital discharge (if sooner) 11. Cognitive Outcome Assessed using the standardised Montreal Cognitive Assessment (MoCA) up to 12-months post-TAVI. 12. Vascular access site related complications (VARC-2 criteria) at 72-hours post-TAVI or hospital discharge (if sooner) and between 6-8 weeks post-TAVI 13. Cost-effectiveness analysis at 12 months _____ Previous secondary outcome measures as of 05/01/2024: 1. Combined incidence of all-cause mortality or non-fatal stroke at 72 hours post-TAVI, or hospital discharge (if sooner) 2. Combined incidence of all-cause mortality, non- | — |
Countries
England, Northern Ireland, Scotland, United Kingdom, Wales
Contacts
Public ContactZahra Jamal
Outcome results
None listed