KogniTa: Impact of Transcatheter Aortic Valve Implantation (TAVI) on Cognitive Functions

Sponsor
Helios University Hospital Wuppertal (Other)
Overall Status
Recruiting
CT.gov ID
NCT05464472
Collaborator
(none)
200
1
30
6.7

Study Details

Study Description

Brief Summary

Interventional implantation of the aortic valve (Transcatheter Aortic Valve Implantation; TAVI) may alter neurocognitive functions. We aim to differentiate the changes in cognitive functions after a TAVI.

Condition or Disease Intervention/Treatment Phase
  • Device: Transcatheter Aortic Valve Implantation (TAVI)

Detailed Description

Interventional implantation of the aortic valve (Transcatheter Aortic Valve Implantation; TAVI) is the treatment of choice for patients with symptomatic aortic valve stenosis >75 years with comorbidities. The reduction in complications and also in mortality after TAVI is due, among other things, to the constant further development of TAVI devices but also to improved implantation technologies. Nevertheless, neurological complications are rare but of relevant impact. These are a.e. due to the passage of the TAVI system into an aorta that is often burdened with atheromatous plaques or the necessity to predilate the calcified aortic valve. Studies using cerebral magnetic resonance imaging (MRI) show that the vast majority of patients after TAVI had lesions in the brain that correspond to at least minimal cerebral infarction. Even if these are asymptomatic, various studies have shown that initially asymptomatic infarcts may be associated with an increased incidence of dementia and cognitive impairment, as well as being predictors of later symptomatic infarctions. Changes in hemodynamics after removal of the aortic stenosis could, on the other hand, improve neurocognitive function. Interestingly, the standard methods primarily investigate motor deficits, while neurocognitive function were currently not tested. The influence of a TAVI on the latter functions is therefore unknown. In this study, we aim to differentiate the changes in cognitive functions after a TAVI immediately after the procedure and after 6 months.

Study Design

Study Type:
Observational
Anticipated Enrollment :
200 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Impact of Transcatheter Aortic Valve Implantation (TAVI) on Cognitive Functions
Actual Study Start Date :
May 31, 2021
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Transcatheter Aortic Valve Implantation

Patients are assessed for cognitive function pre and post transcatheter aortic valve implantation.

Device: Transcatheter Aortic Valve Implantation (TAVI)
Guideline/ FDA approved implantation of a Transcatheter Aortic Valve Implantation (TAVI)

Control matched population

Control matched population are assessed for cognitive function at day 0 and at 6 month

Outcome Measures

Primary Outcome Measures

  1. neurocognitive performance for depression [6 month post TAVI]

    Becks Depression Inventory (BDI)

  2. neurocognitive performance for health status [6 month post TAVI]

    Questionnaire on health status (SF 36)

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • planned TAVI implantation

  • Age ≥ 60

  • Intelligence quotient > 80

  • Sufficient knowledge of German

  • Normal or corrected vision and hearing

Exclusion Criteria:
  • Serious neurological or psychiatric diseases that make participation in the trial procedure impossible

  • Oncological disease with a life expectancy < 12 months

  • pregnancy

Contacts and Locations

Locations

Site City State Country Postal Code
1 Helios Universitätsklinikum Wuppertal Herzzentrum Wuppertal NRW Germany 42117

Sponsors and Collaborators

  • Helios University Hospital Wuppertal

Investigators

  • Study Chair: Marc Vorpahl, Prof. Dr., Helios Wuppertal

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Helios University Hospital Wuppertal
ClinicalTrials.gov Identifier:
NCT05464472
Other Study ID Numbers:
  • Cardio 01
First Posted:
Jul 19, 2022
Last Update Posted:
Jul 19, 2022
Last Verified:
Jul 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Helios University Hospital Wuppertal
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 19, 2022