Aortic StenosisTAVIPSYCHNCT01648309
Neuropsychological Testing in Patients Undergoing Transvascular Aortic Valve Implantation
An observational study of Aortic Stenosis, run by Hadassah Medical Organization at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Aortic Stenosis
- What is being tested?
- Neuropsychological testing
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2012to Sep 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients with severe aortic stenosis that are candidates for TAVI
Who may be able to join
- All patients with severe aortic stenosis that are candidates for TAVI
- Able to perform the testing
- Able to sign informed consent
Who cannot join
- Language barriers precluding the administration of the testing
- Existing dementia
- Existing disease limiting life expectancy to less than 180 days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neuropsychological Testing in Patients Undergoing TAVI
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
- Being tested
- Neuropsychological testing
- Keywords
- aortic stenosis, TAVI, neuropsychological, cognitive, candidates for TAVI
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuropsychological testingOther
This is an observational study
| Study group | Role | What they receive |
|---|---|---|
| TAVI | patients with significant aortic stenosis that are candidates for transvascular aortic valve implantation Receives: Other: Neuropsychological testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2012 (estimated)
- Study startSep 2012
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic StenosisStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ronen Leker, Hadassah Medical Organization
- Investigators
- Ronen R Leker, MD, Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01648309
- Sponsor's protocol ID
- TAVIPSYCH-HMO-CTIL
- Other IDs
- TAVI registry Hadassah, TAVI registry Hadassah
- Acronym
- TAVIPSYCH
- Status last verified
- Aug 2016
- First submitted
- 16 Jul 2012
- Last updated
- 16 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuropsychological Testing in Patients Undergoing TAVI
- ClinicalTrials.gov ID
- NCT01648309
- Acronym / sponsor ID
- TAVIPSYCH / TAVIPSYCH-HMO-CTIL
- Conditions
- Aortic Stenosis
- Keywords
- aortic stenosis, TAVI, neuropsychological, cognitive, candidates for TAVI
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 24 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TAVI | – | Other: Neuropsychological testingpatients with significant aortic stenosis that are candidates for transvascular aortic valve implantation |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with severe aortic stenosis that are candidates for TAVI
Key inclusion criteria (3 listed)
- All patients with severe aortic stenosis that are candidates for TAVI
- Able to perform the testing
- Able to sign informed consent
Key exclusion criteria (3 listed)
- Language barriers precluding the administration of the testing
- Existing dementia
- Existing disease limiting life expectancy to less than 180 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuropsychological testingThis is an observational study | Other | TAVI |
Primary outcome
net change in neuropsychological tests between baseline and day 180 from TAVI
Time frame: 180 days
The study will assess changes in cognitive performance between baseline (prior to TAVI) and 180 days after TAVI
1 secondary outcome
net difference between cognitive measures before TAVI and at day 30 after TAVI
Time frame: 30 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronen R Leker, MD principal investigator
Hadassah Medical Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Stenosis, run by Hadassah Medical Organization at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 16 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
net change in neuropsychological tests between baseline and day 180 from TAVI (time frame: 180 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2016.