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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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.

Conditions
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Cardiovascular Disease, Aortic Valve Stenosis, Cognitive Assessments, Valve Surgery, Transcatheter Valve Replacement, Surgical Valve Replacement

Intervention / Treatment
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* Other: Observational/Cognitive Assessment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 104 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Surgical Aortic Valve Replacement<br>Montreal Cognitive Assessment (MoCA); Trail Making Test Part A; Trail Making Test Part B; Phonemic Fluency (letter fluency) and Semantic Fluency (category). | Other: Observational/Cognitive Assessment<br>* Montreal Cognitive Assessment (MoCA); Trail Making Test Part A; Trail Making Test Part B; Phonemic Fluency (letter fluency) and Semantic Fluency (category).<br>|
| Other: Transcatheter Aortic Valve Replacement<br>Montreal Cognitive Assessment (MoCA); Trail Making Test Part A; Trail Making Test Part B; Phonemic Fluency (letter fluency) and Semantic Fluency (category). | Other: Observational/Cognitive Assessment<br>* Montreal Cognitive Assessment (MoCA); Trail Making Test Part A; Trail Making Test Part B; Phonemic Fluency (letter fluency) and Semantic Fluency (category).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Montreal Cognitive Assessment | Estimate the means and standard deviations of changes in selected cognitive measures between baseline (pre-TAVR or pre-SAVR) and 3 months post-TAVR or post-SAVR, identify baseline correlates of those changes, and characterize baseline cognitive function and cognitive history of patients who undergo TAVR or SAVR. | Three Months | 
| Trail Making |  | 3 months |