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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02971020
Recruitment Status : Completed
First Posted : November 22, 2016
Last Update Posted : March 26, 2018
Sponsor:
Collaborator:
Minneapolis Veterans Affairs Medical Center
Information provided by (Responsible Party):
Santiago Garcia, Minnesota Veterans Medical Research and Education Foundation

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cardiovascular Disease Aortic Valve Stenosis Cognitive Assessments Valve Surgery Transcatheter Valve Replacement Surgical Valve Replacement Other: Observational/Cognitive Assessment Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official 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.
Actual Study Start Date : May 2016
Actual Primary Completion Date : November 12, 2017
Actual Study Completion Date : March 21, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Surgical Aortic Valve Replacement
Montreal Cognitive Assessment (MoCA); Trail Making Test Part A; Trail Making Test Part B; Phonemic Fluency (letter fluency) and Semantic Fluency (category).
 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).
Transcatheter Aortic Valve Replacement
Montreal Cognitive Assessment (MoCA); Trail Making Test Part A; Trail Making Test Part B; Phonemic Fluency (letter fluency) and Semantic Fluency (category).
 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).


Outcome Measures
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Primary Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   up to 104 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02971020


Locations
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United States, Minnesota
Minneapolis VA Health Care System
Minneapolis, Minnesota, United States, 55417
Sponsors and Collaborators
Minnesota Veterans Medical Research and Education Foundation
Minneapolis Veterans Affairs Medical Center
Investigators
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Principal Investigator: Santiago Garcia, MD Minneapolis Veterans Affairs Medical Center
Principal Investigator: Howard Fink, MD Minneapolis Veterans Affairs Medical Center
More Information
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Responsible Party: Santiago Garcia, MD, Minnesota Veterans Medical Research and Education Foundation
ClinicalTrials.gov Identifier: NCT02971020    
Other Study ID Numbers: 4588-A
First Posted: November 22, 2016    Key Record Dates
Last Update Posted: March 26, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Cardiovascular Diseases
Aortic Valve Stenosis
Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
 Mental Disorders
Aortic Valve Disease
Heart Valve Diseases
Heart Diseases
Ventricular Outflow Obstruction