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Clinical Trials/ACTRN12618001114235
ACTRN12618001114235
Terminated
未知

Development of Risk Models for Cognitive Decline and Delirium in Aortic Stenosis and Transcatheter Aortic Valve Implantation (TAVI)

niversity of South Australia0 sites32 target enrollmentJuly 5, 2018

Overview

Phase
未知
Intervention
Not specified
Conditions
Aortic stenosis
Sponsor
niversity of South Australia
Enrollment
32
Status
Terminated
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
July 5, 2018
End Date
May 31, 2022
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
niversity of South Australia

Eligibility Criteria

Inclusion Criteria

  • Inclusion criteria for the TAVI group include undergoing elective TAVI at the Royal Adelaide Hospital, male or female, and aged over 60 years. Participants with a clinical diagnosis of a neurodegenerative condition (including dementia) will be eligible for inclusion as it is reflective of the general older population who would be considered appropriate for cardiovascular procedures and thus will facilitate clinical translation of study results (note: different consent process for those with a clinical diagnosis of dementia).
  • Inclusion criteria for the control group include male or female, and aged over 60 years. Participants with a clinical diagnosis of a neurodegenerative condition including dementia will be eligible for inclusion (note: different consent process for those with a clinical diagnosis of dementia).

Exclusion Criteria

  • Key exclusion criteria include current or recent (within the past year) alcohol or substance abuse or dependence, use of recreational drugs (within the past month), a diagnosed learning disability, insufficient English language, hearing (with aids) or vision (with glasses) to complete assessment tasks.
  • Control participants will be excluded if they are found to have a heart murmur and/or aortic stenosis, a history of cardiovascular disease.
  • TAVI participants will be excluded if they are already enrolled in a TAVI clinical trial.

Outcomes

Primary Outcomes

Not specified

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