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

This study is currently recruiting participants.
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
History of Changes
  Purpose

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.


Condition Intervention
Aortic Stenosis
 Other: Neuropsychological testing

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Neuropsychological Testing in Patients Undergoing TAVI

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 70
Study Start Date: September 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
TAVI
patients with significant aortic stenosis that are candidates for transvascular aortic valve implantation
 Other: Neuropsychological testing
This is an observational study

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All patients with severe aortic stenosis that are candidates for TAVI

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01648309

Contacts
Contact: Ronen R Leker, MD 9722677192 leker@hadassah.org.il
Contact: Haim Danenberg, MD danen@hadassah.org.il

Locations
Israel
Hadassah Medical Center Recruiting
Jerusalem, Israel, 91120
Contact: Hadas Lemberg, PhD     00 972 2 6777572     lhadas@hadassah.org.il    
Sub-Investigator: Haim Danenberg, MD            
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Ronen R Leker, MD Hadassah Medical Organization
  More Information

No publications provided

Responsible Party: Ronen Leker, Director - Stroke Center, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT01648309     History of Changes
Other Study ID Numbers: TAVIPSYCH-HMO-CTIL, TAVI registry Hadassah, TAVI registry Hadassah
Study First Received: July 16, 2012
Last Updated: March 19, 2013
Health Authority: Israel:Ministry of Health - Director General

Keywords provided by Hadassah Medical Organization:
aortic stenosis
TAVI
neuropsychological
cognitive
candidates for TAVI

Additional relevant MeSH terms:
Aortic Valve Stenosis
Constriction, Pathologic
Heart Valve Diseases
Heart Diseases
 Cardiovascular Diseases
Ventricular Outflow Obstruction
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on May 19, 2013