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Clinical Trials/ACTRN12613000083796
ACTRN12613000083796
Recruiting
未知

In patients with severe Aortic Stenosis undergoing Transcatheter Aortic Valve Implantation (TAVI), what associated neurological injury exists as measured radiologically (magnetic resonance imaging), serological markers of neurological injury (s100B and GFAP) and clinically (neurological assessment, neurocognitive assessment, health-related quality of life scales).

Critical Care Research Group (CCRG)0 sites80 target enrollmentJanuary 22, 2013
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ConditionsTranscatheter Aortic Valve Implantation (TAVI)Neurological InjuryCardiovascular - Other cardiovascular diseasesSurgery - Other surgeryStroke - Ischaemic

Overview

Phase
未知
Intervention
Not specified
Conditions
Transcatheter Aortic Valve Implantation (TAVI)
Sponsor
Critical Care Research Group (CCRG)
Enrollment
80
Status
Recruiting
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
January 22, 2013
End Date
TBD
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Critical Care Research Group (CCRG)

Eligibility Criteria

Inclusion Criteria

  • •All consenting patients undergoing transcatheter aortic valve implantation (TAVI) via the transfemoral, transaortic and transapical routes with the Edwards SAPIEN\-XT valve under general anaesthetic.

Exclusion Criteria

  • •1\. Lacks capacity to consent for him or herself.
  • •2\. Pre\-existing neurological impairment measured as modified Rankin Score \>\=3\.
  • •3\. Contraindication to MRI (including incompatible metallic prosthesis/foreign body, inability to lie flat, claustrophobia requiring sedation)
  • •4\. Non or poor English\-speaking due to nature of cognitive testing and unknown validity in such populations
  • •5\. Previous aortic valve repair/replacement.
  • •6\. Coronary artery disease requiring revascularisation (including patients undergoing combined AVR and CABG).

Outcomes

Primary Outcomes

Not specified

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