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

NCT05464472 | Unknown DMC

• 1 other identifier: Cardio 01
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognition Disorder

Keywords

Transcatheter Aortic Valve Implantation (TAVI); Cognitive Function; Aortic stenosis; Stroke; Frailty

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Transcatheter Aortic Valve Implantation

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

Device: Transcatheter Aortic Valve Implantation (TAVI)

Control matched population

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

Interventions

Transcatheter Aortic Valve Implantation (TAVI) DEVICE

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

Transcatheter Aortic Valve Implantation

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• planned TAVI implantation
• Age ≥ 60
• Intelligence quotient \> 80
• Sufficient knowledge of German
• Normal or corrected vision and hearing

You may not qualify if:

• Serious neurological or psychiatric diseases that make participation in the trial procedure impossible
• Oncological disease with a life expectancy \< 12 months
• pregnancy

Sponsors & Collaborators

• Helios University Hospital Wuppertal: lead

Study Sites (1)

Helios Universitätsklinikum Wuppertal Herzzentrum

Wuppertal, North Rhine-Westphalia, 42117, Germany

RECRUITING

MeSH Terms

Conditions

Cognition Disorders; Aortic Valve Stenosis; Stroke; Frailty

Interventions

Transcatheter Aortic Valve Replacement

Condition Hierarchy (Ancestors)

Neurocognitive Disorders; Mental Disorders; Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis Implantation; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Thoracic Surgical Procedures

Study Officials

• Marc Vorpahl, Prof. Dr.

  Helios Wuppertal

  STUDY CHAIR

Central Study Contacts

Melchior Seyfarth, Prof. Dr.

CONTACT

+49202896; marc.vorpahl@hmelchior.seyfarth@helios-gesundheit.deelios-gesundheit.de

Martina Piefke, Prof. Dr.

CONTACT

02302 926; martina.piefke@uni-wh.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2022
• First Posted: July 19, 2022
• Study Start: May 31, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 1, 2023
• Last Updated: July 19, 2022

Record last verified: 2022-07

Locations

DE (1)