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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02971020

Acronym

CAVIAR

Enrollment

Registered

2016-11-22

Start date

2016-05-31

Completion date

2018-03-21

Last updated

2018-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

OTHERObservational/Cognitive Assessment

Montreal Cognitive Assessment (MoCA); Trail Making Test Part A; Trail Making Test Part B; Phonemic Fluency (letter fluency) and Semantic Fluency (category).

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

No minimum to 104 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026