Brief Title
Neuropsychological Testing in Patients Undergoing Transvascular Aortic Valve Implantation
Official Title
Neuropsychological Testing in Patients Undergoing TAVI
Brief Summary
The purpose of this study is to examine the neuropsychological effects of transvascular aortic valve implantation (TAVI). Patients undergoing TAVI usually suffer from congestive heart failure and low cardiac output which may limit their cognitive abilities. TAVI results in significant improvements in cardiac function and therefore may improve cognitive functions. However, TAVI may also be associated with stroke and may therefore have a negative impact on cognition. Therefore, in this study the investigators wish to perform a battery of standardized neuropsychological tests before and after TAVI to test the net effects of TAVI on cognitive performance over time. The investigators plan to include all patients planned to have TAVI in the study and to test them before, 3,7, 30 and 360 days post TAVI with a standardized battery of test.
Study Type
Observational
Primary Outcome
net change in neuropsychological tests between baseline and day 180 from TAVI
Secondary Outcome
net difference between cognitive measures before TAVI and at day 30 after TAVI
Condition
Aortic Stenosis
Intervention
Neuropsychological testing
Study Arms / Comparison Groups
TAVI
Description: patients with significant aortic stenosis that are candidates for transvascular aortic valve implantation
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
0
Start Date
September 2012
Completion Date
September 2014
Primary Completion Date
September 2014
Eligibility Criteria
Inclusion Criteria: - All patients with severe aortic stenosis that are candidates for TAVI - Able to perform the testing - Able to sign informed consent Exclusion Criteria: - Language barriers precluding the administration of the testing - Existing dementia - Existing disease limiting life expectancy to less than 180 days
Gender
All
Ages
60 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Ronen R Leker, MD, ,
Location Countries
Israel
Location Countries
Israel
Administrative Informations
NCT ID
NCT01648309
Organization ID
TAVIPSYCH-HMO-CTIL
Secondary IDs
TAVI registry Hadassah
Responsible Party
Principal Investigator
Study Sponsor
Hadassah Medical Organization
Study Sponsor
Ronen R Leker, MD, Principal Investigator, Hadassah Medical Organization
Verification Date
August 2016