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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

128 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-20

Study Completion Date

2025-05-29

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.

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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.

Conditions

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Cognitive Impairment

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with TAVI

cognitive research battery, MRI, laboratory values

Intervention Type OTHER

cognitive research battery, MRI, laboratory values

Interventions

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cognitive research battery, MRI, laboratory values

Intervention Type OTHER

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

* Persons unable to give consent (e.g. dementia, delirium etc.)
* Magnetic resonance imaging (MR) contraindications
* ophthalmological inability to read

Minimum Eligible Age

19 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes