Impact of TAVI on Cognition, Mood and Health-related Quality of Life
The Impact of Transcatheter Aortic Valve Implantation on Cognition, Mood and Health-related Quality of Life - an Explorative Study
2 other identifiers
observational
128
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2023
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 29, 2020
CompletedFirst Posted
Study publicly available on registry
May 1, 2020
CompletedStudy Start
First participant enrolled
February 20, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 29, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 29, 2025
CompletedJanuary 11, 2023
January 1, 2023
2.3 years
April 29, 2020
January 10, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
cognition
Montreal-Cognitive-Assessment, cognitive test battery
12 months
Secondary Outcomes (1)
health-related quality of life
12 months
Other Outcomes (2)
mood
12 months
MRI
12 months
Study Arms (1)
Patients with TAVI
cognitive research battery, MRI, laboratory values
Interventions
cognitive research battery, MRI, laboratory values
Eligibility Criteria
Patients with percutaneous aortic valve replacement
You may qualify if:
- 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
You may not qualify if:
- Persons unable to give consent (e.g. dementia, delirium etc.)
- Magnetic resonance imaging (MR) contraindications
- ophthalmological inability to read
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical University of Graz
Graz, Styria, 8036, Austria
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andreas Baranyi, Prof.
Medical University Graz, Austria
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof.
Study Record Dates
First Submitted
April 29, 2020
First Posted
May 1, 2020
Study Start
February 20, 2023
Primary Completion
May 29, 2025
Study Completion
May 29, 2025
Last Updated
January 11, 2023
Record last verified: 2023-01