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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transcatheter Aortic Valve Implantation | 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcatheter Aortic Valve Implantation (TAVI) | Device | Guideline/ FDA approved implantation of a Transcatheter Aortic Valve Implantation (TAVI) |
|
| Measure | Description | Time Frame |
|---|---|---|
| neurocognitive performance for depression | Becks Depression Inventory (BDI) | 6 month post TAVI |
| neurocognitive performance for health status | Questionnaire on health status (SF 36) | 6 month post TAVI |
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Inclusion Criteria:
Exclusion Criteria:
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The population is scheduled for TAVI implantation due to symptomatic aortic stenosis. Control is age matched.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Melchior Seyfarth, Prof. Dr. | Contact | +49202896 | 5661 | marc.vorpahl@hmelchior.seyfarth@helios-gesundheit.deelios-gesundheit.de |
| Martina Piefke, Prof. Dr. | Contact | 02302 926 | 778 | martina.piefke@uni-wh.de |
| Name | Affiliation | Role |
|---|---|---|
| Marc Vorpahl, Prof. Dr. | Helios Wuppertal | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helios Universitätsklinikum Wuppertal Herzzentrum | Recruiting | Wuppertal | North Rhine-Westphalia | 42117 | Germany |
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| ID | Type | URL | Comment |
|---|---|---|---|
| BECK DEPRESSION INVENTORY | View IPD |
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| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D001024 | Aortic Valve Stenosis |
| D020521 | Stroke |
| D000073496 | Frailty |
| ID | Term |
|---|---|
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
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| ID | Term |
|---|---|
| D065467 | Transcatheter Aortic Valve Replacement |
| ID | Term |
|---|---|
| D019918 | Heart Valve Prosthesis Implantation |
| D006348 | Cardiac Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| SF-36 QUESTIONNAIRE | View IPD |
| D006331 |
| Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014694 | Ventricular Outflow Obstruction |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019919 | Prosthesis Implantation |
| D019616 | Thoracic Surgical Procedures |