Neuropsychological Testing in Patients Undergoing Transva... | NCT01648309

Studies
Neuropsychological Testing in Patients Undergoing Transvascular Aortic Valve Implantation

NCT01648309

Sponsor

Hadassah Medical Organization

Status

Withdrawn

Last Update Posted

Aug 16, 2016Estimated

Enrollment

0Actual

Phase

Not provided

Conditions

Aortic Stenosis

Interventions

Neuropsychological testing

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
TAVI registry Hadassah
TAVI registry Hadassah	Registry Identifier	TAVI HADASSAH

Status Module

Record Verification Date

Aug 2016

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2012

Primary Completion Date

Sep 2014Actual

Completion Date

Sep 2014Actual

First Submitted Date

Jul 16, 2012

First Submission Date that Met QC Criteria

Jul 23, 2012

First Posted Date

Jul 24, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 15, 2016

Last Update Posted Date

Aug 16, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ronen Leker, Director - Stroke Center, Hadassah Medical OrganizationPrincipal Investigator

Lead Sponsor

Hadassah Medical OrganizationOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
TAVI		patients with significant aortic stenosis that are candidates for transvascular aortic valve implantation	Other: Neuropsychological testing

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Neuropsychological testing	Other	This is an observational study	TAVI

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
net change in neuropsychological tests between baseline and day 180 from TAVI	The study will assess changes in cognitive performance between baseline (prior to TAVI) and 180 days after TAVI	180 days

Secondary Outcomes

Measure	Description	Time Frame
net difference between cognitive measures before TAVI and at day 30 after TAVI	The study will evaluate net differences between scores obtained on cognitive tests at baseline prior to TAVI and day 30 after TAVI	30 days

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

All patients with severe aortic stenosis that are candidates for TAVI

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ronen R Leker, MD	Hadassah Medical Organization	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hadassah Medical Center		Jerusalem		91120	Israel

Condition Browse Module

MeSH Terms

ID	Term
D001024	Aortic Valve Stenosis

Ancestor Terms

ID	Term
D000082862	Aortic Valve Disease
D006349	Heart Valve Diseases
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D009483	Neuropsychological Tests

Ancestor Terms

ID	Term
D011581	Psychological Tests
D004191	Behavioral Disciplines and Activities

Browse Leaves

Not provided

Browse Branches

Not provided