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

• Conditions: Cognition Disorder
• Interventions: Device: Transcatheter Aortic Valve Implantation (TAVI)

• Registration Number: NCT05464472
• Lead Sponsor: Helios University Hospital Wuppertal

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.

Study Timeline

• Study Start: 2021-05-31
• Study First Submitted: 2022-03-27
• Status Verified: 2022-07
• Study First Submitted QC: 2022-07-14
• Last Update Submitted: 2022-07-14
• Study First Posted: 2022-07-19
• Last Update Posted: 2022-07-19
• Primary Completion: 2022-12-31
• Study Completion: 2023-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Transcatheter Aortic Valve Implantation	Transcatheter Aortic Valve Implantation (TAVI)	Patients are assessed for cognitive function pre and post transcatheter aortic valve implantation.

Primary Outcome Measures

Name	Time	Method
neurocognitive performance for depression	6 month post TAVI	Becks Depression Inventory (BDI)
neurocognitive performance for health status	6 month post TAVI	Questionnaire on health status (SF 36)

Trial Locations

Locations (1)

Helios Universitätsklinikum Wuppertal Herzzentrum; 🇩🇪 Wuppertal, NRW, Germany