Impact of TAVI on Cognition, Mood and Health-related Quality of Life

Study Overview
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Brief Summary
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In the proposed study, patients with and without embolic protection devices during Transcatheter Aortic Valve Implantation will be repeatedly examined with a comprehensive psychiatric and cognitive test battery over a post-interventional period of 6 months after TAVI, with regard to the effects on mood, cognitive Performance and health-related Quality of life.

Detailed Description
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The percutaneous aortic valve replacement (TAVI, Transcatheter Aortic Valve Implantation) enables the implantation of a new biological aortic valve at the beating heart. The procedure is performed under local anaesthesia and is a gold standard in the therapy of aortic stenosis, especially in patients with a too high health risk for cardiovascular surgery. In the proposed study, patients with and without embolic protection devices during TAVI will be repeatedly examined with a comprehensive psychiatric and cognitive test battery over a post-interventional period of 6 months after TAVI, with regard to the effects on mood, cognitive Performance and health-related quality of life.

Official Title
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The Impact of Transcatheter Aortic Valve Implantation on Cognition, Mood and Health-related Quality of Life - an Explorative Study

Conditions
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Cognitive Impairment

Intervention / Treatment
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* Other: cognitive research battery, MRI, laboratory values


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written declaration of consent of the study participants to participate in the study after detailed information on the nature, significance, risks and scope of the study. Women and men between the ages of 19 and 90 Clinical indication for TAVI intervention No previous psychiatric illness before TAVI No other serious disease affecting the immune system Exclusion Criteria: Non-compliance with the inclusion criteria Persons unable to give consent (e.g. dementia, delirium etc.) Magnetic resonance imaging (MR) contraindications ophthalmological inability to read

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with TAVI<br>cognitive research battery, MRI, laboratory values | Other: cognitive research battery, MRI, laboratory values<br>* cognitive research battery, MRI, laboratory values<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cognition | Montreal-Cognitive-Assessment, cognitive test battery | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| health-related quality of life | Short Form (36) Health Survey (SF-36): The SF-36 consists of 8 scales. scores. Each scale is directly transformed into a 0-100 scale. A score of 100 is equivalent to no disability. | 12 months |