NCT02971020

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

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: Minnesota Veterans Medical Research and Education Foundation · Academic / Other
• Sex: All
• Age: 104 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cardiovascular Disease
• Aortic Valve Stenosis
• Cognitive Assessments
• Valve Surgery
• Transcatheter Valve Replacement
• Surgical Valve Replacement

Interventions

Type	Name	Description
OTHER	Observational/Cognitive Assessment	Montreal Cognitive Assessment (MoCA); Trail Making Test Part A; Trail Making Test Part B; Phonemic Fluency (letter fluency) and Semantic Fluency (category).

Timeline

• Start date: 2016-05-01
• Primary completion: 2017-11-12
• Completion: 2018-03-21
• First posted: 2016-11-22
• Last updated: 2018-03-26

Locations

1 site across 1 country: United States