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

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.

Study Overview

• Status: Recruiting
• Conditions: Cognition Disorder
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Melchior Seyfarth, Prof. Dr.; Phone Number: 5661 +49202896; Email: marc.vorpahl@hmelchior.seyfarth@helios-gesundheit.deelios-gesundheit.de
• Study Contact Backup: Name: Martina Piefke, Prof. Dr.; Phone Number: 778 02302 926; Email: martina.piefke@uni-wh.de

Study Locations

• Germany
  • NRW
    • Wuppertal, NRW, Germany, 42117
      • Recruiting
      • Helios Universitätsklinikum Wuppertal Herzzentrum
      • Contact: Sarah Christiani; Phone Number: 5605 +49 202 896; Email: sarah.christiani@helios-gesundheit.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The population is scheduled for TAVI implantation due to symptomatic aortic stenosis. Control is age matched.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
neurocognitive performance for depression	Becks Depression Inventory (BDI)	6 month post TAVI
neurocognitive performance for health status	Questionnaire on health status (SF 36)	6 month post TAVI

Collaborators and Investigators

• Sponsor: Helios University Hospital Wuppertal
• Investigators: Study Chair: Marc Vorpahl, Prof. Dr., Helios Wuppertal

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2021
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: March 27, 2022
• First Submitted That Met QC Criteria: July 14, 2022
• First Posted (Actual): July 19, 2022

Study Record Updates

• Last Update Posted (Actual): July 19, 2022
• Last Update Submitted That Met QC Criteria: July 14, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Stroke; Frailty; Cognitive Function; Aortic stenosis; Transcatheter Aortic Valve Implantation (TAVI)
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders
• Other Study ID Numbers: Cardio 01

Plan for Individual participant data (IPD)

Study Data/Documents

1. BECK DEPRESSION INVENTORY
2. SF-36 QUESTIONNAIRE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No