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

M

Medical University of Graz

Status

Not yet enrolling

Conditions

Cognitive Impairment

Treatments

Other: cognitive research battery, MRI, laboratory values

Study type

Observational

Funder types

Other

Identifiers

NCT04371172
32-249 ex19/20 (Other Identifier)
32-249 ex 19/20

Details and patient eligibility

About

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.

Full 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.

Enrollment

128 estimated patients

Sex

All

Ages

19 to 90 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

128 participants in 1 patient group

Patients with TAVI
Description:
cognitive research battery, MRI, laboratory values
Treatment:
Other: cognitive research battery, MRI, laboratory values

Trial contacts and locations

1

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Central trial contact

Albrecht Schmidt, PD.; Andreas Baranyi, Prof.

Data sourced from clinicaltrials.gov

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