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

Cognition Disorder Clinical Trial

— KogniTa  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05464472
• Other study ID #: Cardio 01
• Status: Recruiting
• Start date: May 31, 2021
• Est. completion date: December 1, 2023

Study information

• Verified date: July 2022
• Source: Helios University Hospital Wuppertal
• Contact: Melchior Seyfarth, Prof. Dr.
• Phone: +49202896
• Email: marc.vorpahl[@]hmelchior.seyfarth[@]helios-gesundheit.deelios-gesundheit.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 1, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognition Disorder
• Cognition Disorders

Intervention

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

Locations

Country	Name	City	State
Germany	Helios Universitätsklinikum Wuppertal Herzzentrum	Wuppertal	NRW

Sponsors (1)

Lead Sponsor	Collaborator
Helios University Hospital Wuppertal

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	neurocognitive performance for depression	Becks Depression Inventory (BDI)	6 month post TAVI
Primary	neurocognitive performance for health status	Questionnaire on health status (SF 36)	6 month post TAVI