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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05464472
Acronym
KogniTa
Enrollment
200
Registered
2022-07-19
Start date
2021-05-31
Completion date
2023-12-01
Last updated
2022-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognition Disorder

Keywords

Transcatheter Aortic Valve Implantation (TAVI), Cognitive Function, Aortic stenosis, Stroke, Frailty

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.

Interventions

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

Sponsors

Helios University Hospital Wuppertal
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
neurocognitive performance for depression6 month post TAVIBecks Depression Inventory (BDI)
neurocognitive performance for health status6 month post TAVIQuestionnaire on health status (SF 36)

Countries

Germany

Contacts

Primary ContactMelchior Seyfarth, Prof. Dr.
marc.vorpahl@hmelchior.seyfarth@helios-gesundheit.deelios-gesundheit.de+49202896
Backup ContactMartina Piefke, Prof. Dr.
martina.piefke@uni-wh.de02302 926

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026