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Clinical Trials/NCT05464472
NCT05464472
Unknown
N/A

Impact of Transcatheter Aortic Valve Implantation (TAVI) on Cognitive Functions

Helios University Hospital Wuppertal1 site in 1 country200 target enrollmentMay 31, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
Cognition Disorder
Sponsor
Helios University Hospital Wuppertal
Enrollment
200
Locations
1
Primary Endpoint
neurocognitive performance for depression
Last Updated
3 years ago

Overview

Brief Summary

Interventional implantation of the aortic valve (Transcatheter Aortic Valve Implantation; TAVI) may alter neurocognitive functions. We aim to differentiate the changes in cognitive functions after a TAVI.

Detailed Description

Interventional implantation of the aortic valve (Transcatheter Aortic Valve Implantation; TAVI) is the treatment of choice for patients with symptomatic aortic valve stenosis \>75 years with comorbidities. The reduction in complications and also in mortality after TAVI is due, among other things, to the constant further development of TAVI devices but also to improved implantation technologies. Nevertheless, neurological complications are rare but of relevant impact. These are a.e. due to the passage of the TAVI system into an aorta that is often burdened with atheromatous plaques or the necessity to predilate the calcified aortic valve. Studies using cerebral magnetic resonance imaging (MRI) show that the vast majority of patients after TAVI had lesions in the brain that correspond to at least minimal cerebral infarction. Even if these are asymptomatic, various studies have shown that initially asymptomatic infarcts may be associated with an increased incidence of dementia and cognitive impairment, as well as being predictors of later symptomatic infarctions. Changes in hemodynamics after removal of the aortic stenosis could, on the other hand, improve neurocognitive function. Interestingly, the standard methods primarily investigate motor deficits, while neurocognitive function were currently not tested. The influence of a TAVI on the latter functions is therefore unknown. In this study, we aim to differentiate the changes in cognitive functions after a TAVI immediately after the procedure and after 6 months.

Registry
clinicaltrials.gov
Start Date
May 31, 2021
End Date
December 1, 2023
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Helios University Hospital Wuppertal
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • planned TAVI implantation
  • Intelligence quotient \> 80
  • Sufficient knowledge of German
  • Normal or corrected vision and hearing

Exclusion Criteria

  • Serious neurological or psychiatric diseases that make participation in the trial procedure impossible
  • Oncological disease with a life expectancy \< 12 months
  • pregnancy

Outcomes

Primary Outcomes

neurocognitive performance for depression

Time Frame: 6 month post TAVI

Becks Depression Inventory (BDI)

neurocognitive performance for health status

Time Frame: 6 month post TAVI

Questionnaire on health status (SF 36)

Study Sites (1)

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