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.

Status: Completed
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 104
Healthy Volunteers: No
View:

• 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

Locations
United States
Minnesota
Minneapolis VA Health Care System
Minneapolis
Time Frame
Start Date: May 2016
Completion Date: March 21, 2018
Participants
Target number of participants: 63
Treatments
Other: Surgical Aortic Valve Replacement
Montreal Cognitive Assessment (MoCA); Trail Making Test Part A; Trail Making Test Part B; Phonemic Fluency (letter fluency) and Semantic Fluency (category).
Other: Transcatheter Aortic Valve Replacement
Montreal Cognitive Assessment (MoCA); Trail Making Test Part A; Trail Making Test Part B; Phonemic Fluency (letter fluency) and Semantic Fluency (category).
Sponsors
Collaborators: Minneapolis Veterans Affairs Medical Center
Leads: Minnesota Veterans Medical Research and Education Foundation

This content was sourced from clinicaltrials.gov

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