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.
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Cardiovascular Disease
- Sponsor
- Minnesota Veterans Medical Research and Education Foundation
- Enrollment
- 63
- Locations
- 1
- Primary Endpoint
- Montreal Cognitive Assessment
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief 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.
Detailed Description
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.
Investigators
Santiago Garcia
MD
Minnesota Veterans Medical Research and Education Foundation
Eligibility Criteria
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
Outcomes
Primary Outcomes
Montreal Cognitive Assessment
Time Frame: Three Months
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.
Trail Making
Time Frame: 3 months