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

August 15, 2016 updated by: Ronen Leker, Hadassah Medical Organization

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Jerusalem, Israel, 91120
        • Hadassah Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients with severe aortic stenosis that are candidates for TAVI

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
TAVI
patients with significant aortic stenosis that are candidates for transvascular aortic valve implantation
Other: Neuropsychological testing
This is an observational study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
180 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hadassah Medical Organization

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

July 16, 2012

First Submitted That Met QC Criteria

July 23, 2012

First Posted (Estimate)

July 24, 2012

Study Record Updates

Last Update Posted (Estimate)

August 16, 2016

Last Update Submitted That Met QC Criteria

August 15, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TAVIPSYCH-HMO-CTIL
  • TAVI registry Hadassah (Registry Identifier: TAVI HADASSAH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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