Evaluating the Risk of Cognitive Impairment After Surgical and Transcatheter Aortic Valve Replacement
CAVIAR
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.
1 other identifier
interventional
63
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2016
CompletedFirst Submitted
Initial submission to the registry
September 12, 2016
CompletedFirst Posted
Study publicly available on registry
November 22, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 12, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 21, 2018
CompletedMarch 26, 2018
March 1, 2018
1.5 years
September 12, 2016
March 22, 2018
Conditions
Outcome Measures
Primary Outcomes (2)
Montreal Cognitive Assessment
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.
Three Months
Trail Making
3 months
Study Arms (2)
Surgical Aortic Valve Replacement
OTHERMontreal 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
OTHERMontreal Cognitive Assessment (MoCA); Trail Making Test Part A; Trail Making Test Part B; Phonemic Fluency (letter fluency) and Semantic Fluency (category).
Interventions
Montreal Cognitive Assessment (MoCA); Trail Making Test Part A; Trail Making Test Part B; Phonemic Fluency (letter fluency) and Semantic Fluency (category).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Severe cognitive impairment at baseline (i.e. unable to understand or follow-up study procedures)
- Unable or unwilling to provide informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Minneapolis VA Health Care System
Minneapolis, Minnesota, 55417, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Santiago Garcia, MD
Minneapolis Veterans Affairs Medical Center
- PRINCIPAL INVESTIGATOR
Howard Fink, MD
Minneapolis Veterans Affairs Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
September 12, 2016
First Posted
November 22, 2016
Study Start
May 1, 2016
Primary Completion
November 12, 2017
Study Completion
March 21, 2018
Last Updated
March 26, 2018
Record last verified: 2018-03
Data Sharing
- IPD Sharing
- Will not share