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

Helios University Hospital Wuppertal

Status: Enrolling

Conditions: Cognition Disorder

Treatments: Device: Transcatheter Aortic Valve Implantation (TAVI)

Study type: Observational

Funder types: Other

Identifiers

NCT05464472

Cardio 01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

200 participants in 2 patient groups

Transcatheter Aortic Valve Implantation

Description:

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

Treatment:

Device: Transcatheter Aortic Valve Implantation (TAVI)

Control matched population

Description:

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