Status:
COMPLETED
RESTORE-TAVI Pilot
Lead Sponsor:
Barts & The London NHS Trust
Collaborating Sponsors:
Imperial College London
Conditions:
Frailty
Aortic Stenosis
Eligibility:
All Genders
70+ years
Phase:
NA
Brief Summary
This is a pilot randomised control study assessing the feasibility and effectiveness of a perioperative multi-component intervention aimed at reducing adverse hospital events and improving functional ...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Age \> 70 years
- Ability to provide written informed consent
- Ability to speak English
- Exclusion criteria:
- Clinical instability defined as requiring use of inotropes/mechanical-circulatory support during admission or post-cardiac arrest
- Active delirium (4AT score ≥ 4) at time of recruitment
- Parkinson's disease (Hoehn \& Yahr stage 3-5)
- Recent stroke (within 7 days preceding recruitment)
- Terminal condition (e.g. metastatic cancer) with life expectancy \< 12 months
- Clinical unsuitable for recruitment to trial according to the discretion of the research team
Exclusion
Key Trial Info
Start Date :
June 7 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2025
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06121921
Start Date
June 7 2024
End Date
May 1 2025
Last Update
May 23 2025
Active Locations (1)
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1
Barts and the London NHS Trust
London, United Kingdom, EC1A 7BE