Brief Title
Evaluating the Risk of Cognitive Impairment After Surgical and Transcatheter Aortic Valve Replacement
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.
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 Type
Interventional
Primary Outcome
Montreal Cognitive Assessment
Condition
Cardiovascular Disease
Intervention
Observational/Cognitive Assessment
Study Arms / Comparison Groups
Surgical Aortic Valve Replacement
Description: Montreal Cognitive Assessment (MoCA); Trail Making Test Part A; Trail Making Test Part B; Phonemic Fluency (letter fluency) and Semantic Fluency (category).
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
63
Start Date
May 2016
Completion Date
March 21, 2018
Primary Completion Date
November 12, 2017
Eligibility 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
Gender
All
Ages
N/A - 104 Years
Accepts Healthy Volunteers
No
Contacts
Santiago Garcia, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT02971020
Organization ID
4588-A
Responsible Party
Principal Investigator
Study Sponsor
Minnesota Veterans Medical Research and Education Foundation
Collaborators
Minneapolis Veterans Affairs Medical Center
Study Sponsor
Santiago Garcia, MD, Principal Investigator, Minneapolis Veterans Affairs Medical Center
Verification Date
March 2018