NCT04535076

Cognitive Outcome After Surgical and Transcatheter Aortic Valve Replacement

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Heart and Brain Research Group, Germany · Academic / Other
• Sex: All
• Age: 65 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Aortic valve stenosis is one of the most common types of heart disease in the aging Western population. While surgical cardiac valve replacement (SAVR) is a standard therapy for patients with aortic stenosis, catheter-assisted aortic valve implantation (TAVI) has developed as an alternative to open-heart surgery, especially for high-risk patients. Recently, increased surgeon experience and improved transcatheter valve systems have led to a global trend to use TAVI in patients with low or intermediate risk. Although cognitive impairment after cardiac surgery is well known, the effect of TAVI on cognitive function has not yet been adequately investigated. The aim of this study is to compare the occurrence and progression of delirium, postoperative cognitive decline (POCD), cerebral infarction, and health-related quality of life (QOL) in patients with intermediate risk for catheter-assisted (TAVI) and surgical (SAVR) aortic valve replacement.

Detailed 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 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.

Conditions

• Postoperative Delirium
• Postoperative Cognitive Dysfunction
• Transcatheter Aortic Valve Replacement
• Surgical Aortic Valve Replacement

Interventions

Type	Name	Description
PROCEDURE	Transcatheter Aortic Valve Implantation	Transcatheter Aortic Valve Implantation
PROCEDURE	Surgical Aortic Valve Replacement	Surgical Aortic Valve Replacement

Timeline

• Start date: 2019-02-28
• Primary completion: 2022-12-19
• Completion: 2022-12-19
• First posted: 2020-09-01
• Last updated: 2023-09-22

Locations

1 site across 1 country: Germany