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

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01648309
First Posted: July 24, 2012
Last Update Posted: August 16, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ronen Leker, Hadassah Medical Organization
  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:


Further study details as provided by Ronen Leker, Hadassah Medical Organization:

Primary Outcome Measures:
  • net change in neuropsychological tests between baseline and day 180 from TAVI [ Time Frame: 180 days ]
    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 ]
    The study will evaluate net differences between scores obtained on cognitive tests at baseline prior to TAVI and day 30 after TAVI


Enrollment: 0
Study Start Date: September 2012
Study Completion Date: September 2014
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

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01648309


Locations
Israel
Hadassah Medical Center
Jerusalem, Israel, 91120
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Ronen R Leker, MD Hadassah Medical Organization
  More Information

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 ( Registry Identifier: TAVI HADASSAH )
First Submitted: July 16, 2012
First Posted: July 24, 2012
Last Update Posted: August 16, 2016
Last Verified: August 2016

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

Additional relevant MeSH terms:
Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction