Neuropsychological Testing in Patients Undergoing Transvascular Aortic Valve Implantation

NCT ID: NCT01648309

Last Updated: 2016-08-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2012-09-30

Study Completion Date

2014-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Aortic Stenosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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TAVI

patients with significant aortic stenosis that are candidates for transvascular aortic valve implantation

Neuropsychological testing

Intervention Type OTHER

This is an observational study

Interventions

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Neuropsychological testing

This is an observational study

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hadassah Medical Organization

OTHER

Sponsor Role lead

Responsible Party

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Ronen Leker

Director - Stroke Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ronen R Leker, MD

Role: PRINCIPAL_INVESTIGATOR

Hadassah Medical Organization

Locations

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Hadassah Medical Center

Jerusalem, , Israel

Site Status

Countries

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Israel

Other Identifiers

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TAVI registry Hadassah

Identifier Type: -

Identifier Source: secondary_id

TAVI registry Hadassah

Identifier Type: REGISTRY

Identifier Source: secondary_id

TAVIPSYCH-HMO-CTIL

Identifier Type: -

Identifier Source: org_study_id

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