Neuropsychological Testing in Patients Undergoing Transvascular Aortic Valve Implantation (TAVIPSYCH)
This study is currently recruiting participants.
Verified March 2013 by Hadassah Medical Organization
Sponsor:
Hadassah Medical Organization
Information provided by (Responsible Party):
Ronen Leker, Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01648309
First received: July 16, 2012
Last updated: March 19, 2013
Last verified: March 2013
| Tracking Information | |||||||||
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| First Received Date ICMJE | July 16, 2012 | ||||||||
| Last Updated Date | March 19, 2013 | ||||||||
| Start Date ICMJE | September 2012 | ||||||||
| Estimated Primary Completion Date | September 2014 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
net change in neuropsychological tests between baseline and day 180 from TAVI [ Time Frame: 180 days ] [ Designated as safety issue: No ] The study will assess changes in cognitive performance between baseline (prior to TAVI) and 180 days after TAVI |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01648309 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
net difference between cognitive measures before TAVI and at day 30 after TAVI [ Time Frame: 30 days ] [ Designated as safety issue: No ] The study will evaluate net differences between scores obtained on cognitive tests at baseline prior to TAVI and day 30 after TAVI |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Neuropsychological Testing in Patients Undergoing Transvascular Aortic Valve Implantation | ||||||||
| Official Title ICMJE | Neuropsychological Testing in Patients Undergoing TAVI | ||||||||
| 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. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | All patients with severe aortic stenosis that are candidates for TAVI |
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| Condition ICMJE | Aortic Stenosis | ||||||||
| Intervention ICMJE | Other: Neuropsychological testing
This is an observational study |
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| Study Group/Cohort (s) | TAVI
patients with significant aortic stenosis that are candidates for transvascular aortic valve implantation
Intervention: Other: Neuropsychological testing |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 70 | ||||||||
| Estimated Completion Date | September 2014 | ||||||||
| Estimated Primary Completion Date | September 2014 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 60 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Israel | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01648309 | ||||||||
| Other Study ID Numbers ICMJE | TAVIPSYCH-HMO-CTIL, TAVI registry Hadassah, TAVI registry Hadassah | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Ronen Leker, Hadassah Medical Organization | ||||||||
| Study Sponsor ICMJE | Hadassah Medical Organization | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Hadassah Medical Organization | ||||||||
| Verification Date | March 2013 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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