Neuropsychological Testing in Patients Undergoing Transvascular Aortic Valve Implantation (TAVIPSYCH)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Hadassah Medical Organization
Sponsor:
Information provided by (Responsible Party):
Ronen Leker, Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01648309
First received: July 16, 2012
Last updated: March 19, 2013
Last verified: March 2013

July 16, 2012
March 19, 2013
September 2012
September 2014   (final data collection date for primary outcome measure)
net change in neuropsychological tests between baseline and day 180 from TAVI [ Time Frame: 180 days ] [ Designated as safety issue: No ]
The study will assess changes in cognitive performance between baseline (prior to TAVI) and 180 days after TAVI
Same as current
Complete list of historical versions of study NCT01648309 on ClinicalTrials.gov Archive Site
net difference between cognitive measures before TAVI and at day 30 after TAVI [ Time Frame: 30 days ] [ Designated as safety issue: No ]
The study will evaluate net differences between scores obtained on cognitive tests at baseline prior to TAVI and day 30 after TAVI
Same as current
Not Provided
Not Provided
 
Neuropsychological Testing in Patients Undergoing Transvascular Aortic Valve Implantation
Neuropsychological Testing in Patients Undergoing TAVI

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

All patients with severe aortic stenosis that are candidates for TAVI

Aortic Stenosis
Other: Neuropsychological testing
This is an observational study
TAVI
patients with significant aortic stenosis that are candidates for transvascular aortic valve implantation
Intervention: Other: Neuropsychological testing
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
70
September 2014
September 2014   (final data collection date for primary outcome measure)

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
Both
60 Years and older
No
Contact: Ronen R Leker, MD 9722677192 leker@hadassah.org.il
Contact: Haim Danenberg, MD danen@hadassah.org.il
Israel
 
NCT01648309
TAVIPSYCH-HMO-CTIL, TAVI registry Hadassah, TAVI registry Hadassah
No
Ronen Leker, Hadassah Medical Organization
Hadassah Medical Organization
Not Provided
Principal Investigator: Ronen R Leker, MD Hadassah Medical Organization
Hadassah Medical Organization
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP