Cognition DisorderKogniTaNCT05464472
Impact of Transcatheter Aortic Valve Implantation (TAVI) on Cognitive Functions
An observational study of Cognition Disorder, run by Helios University Hospital Wuppertal at 1 site in Germany.
Trial summary
Interventional implantation of the aortic valve (Transcatheter Aortic Valve Implantation; TAVI) may alter neurocognitive functions. We aim to differentiate the changes in cognitive functions after a TAVI. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Cognition Disorder
- What is being tested?
- Transcatheter Aortic Valve Implantation (TAVI)
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- 31 May 2021to 1 Dec 2023
- 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: The population is scheduled for TAVI implantation due to symptomatic aortic stenosis. Control is age matched.
Who may be able to join
- planned TAVI implantation
- Age ≥ 60
- Intelligence quotient > 80
- Sufficient knowledge of German
- Normal or corrected vision and hearing
Who cannot join
- Serious neurological or psychiatric diseases that make participation in the trial procedure impossible
- Oncological disease with a life expectancy < 12 months
- pregnancy
Trial locations and contacts
1 site in 1 country.
Melchior Seyfarth, Prof. Dr. contact
marc.vorpahl@hmelchior.seyfarth@helios-gesundheit.deelios-gesundheit.de
Germany1 site, 1 recruiting
- Recruiting
Helios Universitätsklinikum Wuppertal Herzzentrum
Wuppertal, North Rhine-Westphalia, 42117
Sarah Christiani, +49 202 896 ext. 5605, sarah.christiani@helios-gesundheit.de
About this study
Interventional implantation of the aortic valve (Transcatheter Aortic Valve Implantation; TAVI) may alter neurocognitive functions. We aim to differentiate the changes in cognitive functions after a TAVI.
Read the detailed description
Interventional implantation of the aortic valve (Transcatheter Aortic Valve Implantation; TAVI) is the treatment of choice for patients with symptomatic aortic valve stenosis >75 years with comorbidities. The reduction in complications and also in mortality after TAVI is due, among other things, to the constant further development of TAVI devices but also to improved implantation technologies. Nevertheless, neurological complications are rare but of relevant impact. These are a.e. due to the passage of the TAVI system into an aorta that is often burdened with atheromatous plaques or the necessity to predilate the calcified aortic valve. Studies using cerebral magnetic resonance imaging (MRI) show that the vast majority of patients after TAVI had lesions in the brain that correspond to at least minimal cerebral infarction. Even if these are asymptomatic, various studies have shown that initially asymptomatic infarcts may be associated with an increased incidence of dementia and cognitive impairment, as well as being predictors of later symptomatic infarctions. Changes in hemodynamics after removal of the aortic stenosis could, on the other hand, improve neurocognitive function. Interestingly, the standard methods primarily investigate motor deficits, while neurocognitive function were currently not tested. The influence of a TAVI on the latter functions is therefore unknown. In this study, we aim to differentiate the changes in cognitive functions after a TAVI immediately after the procedure and after 6 months.
- Conditions
- Cognition Disorder
- Being tested
- Transcatheter Aortic Valve Implantation (TAVI)
- Keywords
- Transcatheter Aortic Valve Implantation (TAVI), Cognitive Function, Aortic stenosis, Stroke, Frailty
- Medical subject headings
- Cognition Disorders, Aortic Valve Stenosis, Stroke, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcatheter Aortic Valve Implantation (TAVI)Device
Guideline/ FDA approved implantation of a Transcatheter Aortic Valve Implantation (TAVI)
| Study group | Role | What they receive |
|---|---|---|
| Transcatheter Aortic Valve Implantation | Patients are assessed for cognitive function pre and post transcatheter aortic valve implantation. Receives: Device: Transcatheter Aortic Valve Implantation (TAVI) | |
| Control matched population | Control matched population are assessed for cognitive function at day 0 and at 6 month |
What is being measured
The primary outcome is the main question the study is designed to answer.
neurocognitive performance for depression
Becks Depression Inventory (BDI)
Measured: 6 month post TAVI
neurocognitive performance for health status
Questionnaire on health status (SF 36)
Measured: 6 month post TAVI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2022
- Study start31 May 2021
- Primary completion31 Dec 2022 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognition DisorderStudies of the same condition, open and under way.
- 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helios University Hospital Wuppertal
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc Vorpahl, Prof. Dr., Study chair, Helios Wuppertal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05464472
- Sponsor's protocol ID
- Cardio 01
- Acronym
- KogniTa
- Status last verified
- Jul 2022
- First submitted
- 27 Mar 2022
- Last updated
- 19 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Transcatheter Aortic Valve Implantation (TAVI) on Cognitive Functions
- ClinicalTrials.gov ID
- NCT05464472
- Acronym / sponsor ID
- KogniTa / Cardio 01
- Conditions
- Cognition Disorder
- Keywords
- Transcatheter Aortic Valve Implantation (TAVI), Cognitive Function, Aortic stenosis, Stroke, Frailty
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Helios University Hospital WuppertalUniversity, hospital or other
- Study start
- 31 May 2021 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 19 Jul 2022 (actual)
- 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.
Interventional implantation of the aortic valve (Transcatheter Aortic Valve Implantation; TAVI) may alter neurocognitive functions. We aim to differentiate the changes in cognitive functions after a TAVI.
Detailed description
Interventional implantation of the aortic valve (Transcatheter Aortic Valve Implantation; TAVI) is the treatment of choice for patients with symptomatic aortic valve stenosis >75 years with comorbidities. The reduction in complications and also in mortality after TAVI is due, among other things, to the constant further development of TAVI devices but also to improved implantation technologies. Nevertheless, neurological complications are rare but of relevant impact. These are a.e. due to the passage of the TAVI system into an aorta that is often burdened with atheromatous plaques or the necessity to predilate the calcified aortic valve. Studies using cerebral magnetic resonance imaging (MRI) show that the vast majority of patients after TAVI had lesions in the brain that correspond to at least minimal cerebral infarction. Even if these are asymptomatic, various studies have shown that initially asymptomatic infarcts may be associated with an increased incidence of dementia and cognitive impairment, as well as being predictors of later symptomatic infarctions. Changes in hemodynamics after removal of the aortic stenosis could, on the other hand, improve neurocognitive function. Interestingly, the standard methods primarily investigate motor deficits, while neurocognitive function were currently not tested. The influence of a TAVI on the latter functions is therefore unknown. In this study, we aim to differentiate the changes in cognitive functions after a TAVI immediately after the procedure and after 6 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transcatheter Aortic Valve Implantation | – | Device: Transcatheter Aortic Valve Implantation (TAVI)Patients are assessed for cognitive function pre and post transcatheter aortic valve implantation. |
| Control matched population | – | –Control matched population are assessed for cognitive function at day 0 and at 6 month |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population is scheduled for TAVI implantation due to symptomatic aortic stenosis. Control is age matched.
Key inclusion criteria (5 listed)
- planned TAVI implantation
- Age ≥ 60
- Intelligence quotient > 80
- Sufficient knowledge of German
- Normal or corrected vision and hearing
Key exclusion criteria (3 listed)
- Serious neurological or psychiatric diseases that make participation in the trial procedure impossible
- Oncological disease with a life expectancy < 12 months
- pregnancy
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 |
|---|---|---|
| Transcatheter Aortic Valve Implantation (TAVI)Guideline/ FDA approved implantation of a Transcatheter Aortic Valve Implantation (TAVI) | Device | Transcatheter Aortic Valve Implantation |
Primary outcome
neurocognitive performance for depression
Time frame: 6 month post TAVI
Becks Depression Inventory (BDI)
neurocognitive performance for health status
Time frame: 6 month post TAVI
Questionnaire on health status (SF 36)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2022.
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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.
Melchior Seyfarth, Prof. Dr. contact
marc.vorpahl@hmelchior.seyfarth@helios-gesundheit.deelios-gesundheit.de
Marc Vorpahl, Prof. Dr. study chair
Helios Wuppertal
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 Cognition Disorder, run by Helios University Hospital Wuppertal at 1 site in Germany.
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 5 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: status not confirmed, as of the sponsor's last update on 19 Jul 2022. 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Melchior Seyfarth, Prof. Dr. (+49202896 ext. 5661, marc.vorpahl@hmelchior.seyfarth@helios-gesundheit.deelios-gesundheit.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
neurocognitive performance for depression (time frame: 6 month post TAVI). The study lists 2 primary outcomes in all. 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 19 Jul 2022.