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Completed

NCT Number: NCT02971020

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

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.

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Key information

Conditions

Cardiovascular Disease Aortic Valve Disease Aortic Valve Stenosis Cardiovascular Diseases Cognitive Assessments Heart Diseases Heart Valve Diseases Surgical Valve Replacement Transcatheter Valve Replacement Valve Surgery Ventricular Outflow Obstruction

Age range

Up to 104 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Minneapolis VA Health Care System

Minneapolis, Minnesota, 55417, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Observational/Cognitive Assessment

Other

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

Primary outcomes

  1. 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.

  2. Trail Making

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Minnesota Veterans Medical Research and Education Foundation

Other

Collaborators

  • Minneapolis Veterans Affairs Medical Center

Registry information

Official study title

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.

Acronym: CAVIAR

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Nov 22, 2016
Registry last updated
Mar 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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