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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-31

Study Completion Date

2023-12-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cognition Disorder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Transcatheter Aortic Valve Implantation

Patients are assessed for cognitive function pre and post transcatheter aortic valve implantation.

Transcatheter Aortic Valve Implantation (TAVI)

Intervention Type DEVICE

Guideline/ FDA approved implantation of a Transcatheter Aortic Valve Implantation (TAVI)

Control matched population

Control matched population are assessed for cognitive function at day 0 and at 6 month

No interventions assigned to this group

Interventions

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Transcatheter Aortic Valve Implantation (TAVI)

Guideline/ FDA approved implantation of a Transcatheter Aortic Valve Implantation (TAVI)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* planned TAVI implantation
* Age ≥ 60
* 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

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No