Cognitive Outcome After Surgical and Transcatheter Aortic Valve Replacement

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.

Conditions

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

Interventions

PROCEDURE

Transcatheter Aortic Valve Implantation

Transcatheter Aortic Valve Implantation

PROCEDURE

Surgical Aortic Valve Replacement

Surgical Aortic Valve Replacement

Sponsors & Collaborators

• Heart and Brain Research Group, Germany

  lead OTHER

Principal Investigators

• Martin Jünemann, Dr.med.M.Sc. · Clinic for Neurology, University Hospital Giessen

• Marius Butz, Dipl.-Psych. · Department of Cardiac Surgery, Kerckhoff Clinic Bad Nauheim

• Tibo Gerriets, Prof.Dr.med. · Department of Neurology, Gesundheitszentrum Wetterau

• Markus Schönburg, Prof.Dr.med. · Department of Cardiac Surgery, Kerckhoff Clinic Bad Nauheim

• Won-Keun Kim, Dr.med. · Department of Cardiac Surgery, Kerckhoff Clinic Bad Nauheim

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

65 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-02-28

Primary Completion

2022-12-19

Completion

2022-12-19

Countries

• Germany

Study Locations