Cognitive Outcome After Surgical and Transcatheter Aortic Valve Replacement
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Postoperative Cognitive Dysfunction
- Postoperative Delirium
- Surgical Aortic Valve Replacement
- Transcatheter Aortic Valve Replacement
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Double (Investigator, Outcomes Assessor)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 65 years and 85 years
- Gender
- Both males and females
Description
The present project is a substudy of the DEDICATE Trial (ID: NCT03112980). It is a randomized intervention study taking place at the Kerckhoff-Klink Bad Nauheim Germany (Campus Justus Liebig University Giessen) involving 100 patients undergoing aortic valve replacement (TAVI vs. SAVR) with a focus o...
The present project is a substudy of the DEDICATE Trial (ID: NCT03112980). It is a randomized intervention study taking place at the Kerckhoff-Klink Bad Nauheim Germany (Campus Justus Liebig University Giessen) involving 100 patients undergoing aortic valve replacement (TAVI vs. SAVR) with a focus on cognitive outcome. A detailed assessment of psychological and health-related functions will be performed before intervention, during hospitalization and 3 months after intervention. During hospitalization, the occurrence and progression of delirium will be assessed with the Intensive Care Delirium Screening Checklist (ICDSC). Other cognitive data will be collected before and 3 months after surgery with a selected and comprehensive neuropsychological test battery, including the evaluation of attention, word fluency, executive functions and various functional areas of memory. In addition, parameters of health-related QOL will be collected before and 3 months after the intervention using the SF-36, and information on anxiety and depression will be collected using the Hospital Anxiety and Depression Scale (HADS). A few days after the intervention, magnetic resonance images of the brain will be acquired to assess cerebral infarction.
Tracking Information
- NCT #
- NCT04535076
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Martin Jünemann, Dr.med.M.Sc. Clinic for Neurology, University Hospital Giessen Principal Investigator: Marius Butz, Dipl.-Psych. Department of Cardiac Surgery, Kerckhoff Clinic Bad Nauheim Principal Investigator: Tibo Gerriets, Prof.Dr.med. Department of Neurology, Gesundheitszentrum Wetterau Principal Investigator: Markus Schönburg, Prof.Dr.med. Department of Cardiac Surgery, Kerckhoff Clinic Bad Nauheim Principal Investigator: Won-Keun Kim, Dr.med. Department of Cardiac Surgery, Kerckhoff Clinic Bad Nauheim
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