Clinical trial NCT05464472: Impact of Transcatheter Aortic Valve Implantation (TAVI) on Cognitive Functions
Official title: Impact of Transcatheter Aortic Valve Implantation (TAVI) on Cognitive Functions
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cognition Disorder
Keywords: Transcatheter Aortic Valve Implantation (TAVI)
Cognitive Function
Aortic stenosis
Stroke
Frailty
Lead sponsor: Helios University Hospital Wuppertal
Sponsor class: OTHER
First posted: 2022-07-19
Enrollment: 200
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population is scheduled for TAVI implantation due to symptomatic aortic stenosis. Control is age matched.

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.

Eligibility criteria: 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

Primary outcomes:
measure: neurocognitive performance for depression
timeFrame: 6 month post TAVI
measure: neurocognitive performance for health status
timeFrame: 6 month post TAVI
Secondary outcomes:
Other outcomes:
Locations:
city: Wuppertal
country: Germany
facility: Helios Universitätsklinikum Wuppertal Herzzentrum
state: NRW
Study officials:
affiliation: Helios Wuppertal
name: Marc Vorpahl, Prof. Dr.
role: STUDY_CHAIR
References: