Neuropsychological Testing in Patients Undergoing Transvascular Aortic Valve Implantation

NCT01648309 | Withdrawn

• 2 other identifiers: TAVIPSYCH-HMO-CTILTAVI registry Hadassah
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Aortic Stenosis

Keywords

aortic stenosis; TAVI; neuropsychological; cognitive; candidates for TAVI

Outcome Measures

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

  180 days

Secondary Outcomes (1)

• net difference between cognitive measures before TAVI and at day 30 after TAVI

  30 days

Study Arms (1)

TAVI

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

Other: Neuropsychological testing

Interventions

Neuropsychological testing OTHER

This is an observational study

TAVI

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients with severe aortic stenosis that are candidates for TAVI

You may qualify if:

• All patients with severe aortic stenosis that are candidates for TAVI
• Able to perform the testing
• Able to sign informed consent

You may not qualify if:

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

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Study Sites (1)

Hadassah Medical Center

Jerusalem, 91120, Israel

Location

MeSH Terms

Conditions

Aortic Valve Stenosis

Interventions

Neuropsychological Tests

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Psychological Tests; Behavioral Disciplines and Activities

Study Officials

• Ronen R Leker, MD

  Hadassah Medical Organization

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director - Stroke Center

Study Record Dates

• First Submitted: July 16, 2012
• First Posted: July 24, 2012
• Study Start: September 1, 2012
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: August 16, 2016

Record last verified: 2016-08

Locations

IL (1)