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WithdrawnNCT01648309TAVIPSYCHUpdated Aug 16, 2016

Neuropsychological Testing in Patients Undergoing Transvascular Aortic Valve Implantation

An observational study in Aortic Stenosis, sponsored by Hadassah Medical Organization. Withdrawn at 1 site in Israel. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2016-08-16.

Sponsored by Hadassah Medical Organization · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
0
Ages
60 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Aortic Stenosis

Keywords

  • aortic stenosis
  • TAVI
  • neuropsychological
  • cognitive
  • candidates for TAVI
03

In context

Aortic Valve Stenosis

1,006 studies on the registry are indexed under Aortic Valve Stenosis; 284 are open to participants now.

Browse Aortic Valve Stenosis studies →

Lead sponsor

Hadassah Medical Organization is the lead sponsor of 674 studies on the registry; 55 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All patients with severe aortic stenosis that are candidates for TAVI

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Language barriers precluding the administration of the testing
  • Existing dementia
  • Existing disease limiting life expectancy to less than 180 days
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
0 participants (actual)

Groups and cohorts

  • TAVI

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

    Other: Neuropsychological testing

Interventions

  • OtherNeuropsychological testing

    This is an observational study

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 180 days

Secondary outcomes

  1. 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

    Time frame: 30 days

07

Study locations

1 site
  • Hadassah Medical Center
    Jerusalem, 91120, Israel
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 16, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01648309
Responsible party
Ronen Leker (Director - Stroke Center, Hadassah Medical Organization) — Principal investigator
First posted
Jul 24, 2012
Start date
Sep 2012
Primary completion
Sep 2014
Completion
Sep 2014
Last update
Aug 16, 2016

Study contacts

Ronen R Leker, MD
principal investigator · Hadassah Medical Organization

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.

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