Impact of TAVI on Cognition, Mood and Health-related Quality of Life
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Patients with TAVI cognitive research battery, MRI, laboratory values |
Other: cognitive research battery, MRI, laboratory values
cognitive research battery, MRI, laboratory values
|
Outcome Measures
Primary Outcome Measures
- cognition [12 months]
Montreal-Cognitive-Assessment, cognitive test battery
Secondary Outcome Measures
- health-related quality of life [12 months]
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.
Other Outcome Measures
- mood [12 months]
Hospital Anxiety and Depression Scale (HADS): A person can score between 0 and 21 for either anxiety or depression); Montgomery-Åsberg Depression Rating Scale: usual cutoff points are: 0 to 6 - normal, 7 to 19 - mild depression, 20 to 34 - moderate depression, >34 - severe Depression
- MRI [12 months]
MRI
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Medical University of Graz | Graz | Styria | Austria | 8036 |
Sponsors and Collaborators
- Medical University of Graz
Investigators
- Principal Investigator: Andreas Baranyi, Prof., Medical University Graz, Austria
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 32-249 ex 19/20
- 32-249 ex19/20