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

January 10, 2023 updated by: Andreas Baranyi, Medical University of Graz

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

128

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Austria
    • Styria
      • Graz, Styria, Austria, 8036
        • Medical University of Graz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with percutaneous aortic valve replacement

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with TAVI
cognitive research battery, MRI, laboratory values
Other: cognitive research battery, MRI, laboratory values
cognitive research battery, MRI, laboratory values

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cognition
Time Frame: 12 months
Montreal-Cognitive-Assessment, cognitive test battery
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
health-related quality of life
Time Frame: 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.
12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
mood
Time Frame: 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
12 months
MRI
Time Frame: 12 months
MRI
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Graz

Investigators

  • Principal Investigator: Andreas Baranyi, Prof., Medical University Graz, Austria

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 20, 2023

Primary Completion (Anticipated)

May 29, 2025

Study Completion (Anticipated)

May 29, 2025

Study Registration Dates

First Submitted

April 29, 2020

First Submitted That Met QC Criteria

April 29, 2020

First Posted (Actual)

May 1, 2020

Study Record Updates

Last Update Posted (Estimate)

January 11, 2023

Last Update Submitted That Met QC Criteria

January 10, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 32-249 ex 19/20
  • 32-249 ex19/20 (Other Identifier: Ethikkommission, Medical university of Graz)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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