Evaluating the Risk of Cognitive Impairment After Surgical and Transcatheter Aortic Valve Replacement



Status:Completed
Conditions:Cognitive Studies, Peripheral Vascular Disease, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases, Psychiatry / Psychology
Healthy:No
Age Range:Any - 104
Updated:4/17/2018
Start Date:May 2016
End Date:March 21, 2018

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Trial Summary
Trial Overview
Inclusion Criteria

Proposal for Collection of Patient Data to Aid in Design of an Observational Study (i.e. Preparatory to Research) Evaluating Risk of Cognitive Impairment After Surgical and Transcatheter Valve Replacement.

The investigators are conducting a pilot study to compare cognitive outcomes among Veterans
with severe aortic valve stenosis who are scheduled to undergo either aortic valve
replacement.

The investigators are conducting a pilot study to compare cognitive outcomes in up to 60
Veterans with severe aortic valve stenosis who are scheduled to undergo either transcatheter
aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) at the
Minneapolis VA Health Care System. Participants will be administered a short battery of
cognitive tests before and three months after TAVR or SAVR over/up to a two year study
period.

Inclusion Criteria:

- Severe aortic stenosis (AVA: 1 cm2 and/or mean gradient =or > 40 mmHg and/or peak
velocity > 4 m/s)

- Scheduled to undergo either surgical or transcatheter aortic valve replacement at the
Minneapolis VA Health Care System

Exclusion Criteria:

- Severe cognitive impairment at baseline (i.e. unable to understand or follow-up study
procedures)

- Unable or unwilling to provide informed consent
We found this trial at
1
site
Minneapolis VA Health Care System
Minneapolis, Minnesota 55417
Phone: 612-467-3662
?
mi
from
Minneapolis, MN
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