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

Not Applicable

Completed

• Conditions: Surgical Valve Replacement; Transcatheter Valve Replacement; Cardiovascular Disease; Valve Surgery; Aortic Valve Stenosis; Cognitive Assessments
• Interventions: Other: Observational/Cognitive Assessment

• Registration Number: NCT02971020
• Lead Sponsor: Minnesota Veterans Medical Research and Education Foundation

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.

Study Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-09-12
• Study First Submitted QC: 2016-11-21
• Study First Posted: 2016-11-22
• Primary Completion: 2017-11-12
• Status Verified: 2018-03
• Study Completion: 2018-03-21
• Last Update Submitted: 2018-03-22
• Last Update Posted: 2018-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Surgical Aortic Valve Replacement	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).
Transcatheter Aortic Valve Replacement	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).

Primary Outcome Measures

Name	Time	Method
Montreal Cognitive Assessment	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	3 months

Trial Locations

Locations (1)

Minneapolis VA Health Care System; 🇺🇸 Minneapolis, Minnesota, United States