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

Cognitive Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04371172
• Other study ID #: 32-249 ex 19/20
• Secondary ID: 32-249 ex19/20
• Status: Not yet recruiting
• Start date: February 20, 2023
• Est. completion date: May 29, 2025

Study information

• Verified date: January 2023
• Source: Medical University of Graz
• Contact: Andreas Baranyi, Prof.
• Phone: 0043-316-385-86241
• Email: an.baranyi[@]medunigraz.at
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 128
• Est. completion date: May 29, 2025
• Est. primary completion date: May 29, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Impairment

Intervention

Other:
• cognitive research battery, MRI, laboratory values
cognitive research battery, MRI, laboratory values

Locations

Country	Name	City	State
Austria	Medical University of Graz	Graz	Styria

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	mood	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	12 months
Other	MRI	MRI	12 months
Primary	cognition	Montreal-Cognitive-Assessment, cognitive test battery	12 months
Secondary	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