Impact of TAVI on Cognition, Mood and Health-related Quality of Life
- Conditions
- Cognitive Impairment
- Interventions
- Other: cognitive research battery, MRI, laboratory values
- Registration Number
- NCT04371172
- Lead Sponsor
- Medical University of Graz
- 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.
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 128
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients with TAVI cognitive research battery, MRI, laboratory values cognitive research battery, MRI, laboratory values
- Primary Outcome Measures
Name Time Method cognition 12 months Montreal-Cognitive-Assessment, cognitive test battery
- Secondary Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (1)
Medical University of Graz
🇦🇹Graz, Styria, Austria