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This study plans to investigate the relationship between cognitive status pre-procedure, and clinical outcomes at 3 months in patients undergoing transcatheter aortic valve implantation (TAVI).
This study plans to investigate the relationship between cognitive status pre-procedure, as assessed using the Montreal Cognitive Assessment (MoCA) administered on a tablet, and clinical outcomes at 3 months as assessed by the VARC2 criteria, in patients undergoing transcatheter aortic valve implantation (TAVI)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study cohort | Adult (>18 years) patients with aortic stenosis in whom TAVI is planned and who perform their pre-TAVI work-up in our centre will be invited to undergo cognitive assessment using the MoCA at the time of their hospitalization for pre-TAVI work-up. The MoCA will be administered by trained professionals with MoCA certification. Clinical outcomes, as assessed by the VARC2 criteria, will be collected for all patients at 3 months after the TAVI procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MoCA cognitive assessment | Other | cognitive assessment using the validated MoCA test administered via an application on an iPad |
|
| Measure | Description | Time Frame |
|---|---|---|
| All-cause death | Safety outcome at 3 months as assessed by the VARC2 criteria: all-cause death | through 30 days after the TAVI procedure |
| Stroke | Safety outcome at 30 days as assessed by the VARC2 criteria: stroke | through 30 days after the TAVI procedure |
| life-threatening bleed | Safety outcome at 30 days as assessed by the VARC2 criteria: life-threatening bleed | through 30 days after the TAVI procedure |
| Combined VARC2 safety outcome | Safety criteria (within 30 days of the procedure) include all-cause death; stroke; life-threatening bleed; renal insufficiency; coronary artery obstruction requiring intervention; major vascular complication; valve dysfunction. Clinical Efficacy criteria (30 days to 3 months after the procedure) include: all-cause death; stroke; re-admission for valve-rela | through 30 days after the TAVI procedure |
| Combined VARC2 efficacy outcome | Clinical Efficacy criteria (30 days to 3 months after the procedure) include: all-cause death; stroke; re-admission for valve-related symptoms or worsening heart failure; NYHA Class III or IV; valve-related dysfunction. | through 30 days after the TAVI procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Time required for MoCA | Length of time required to administer the MoCA test using a tablet | At the time of MoCA completion |
| Biological parameters pre-procedure | Blood count; prothrombin; TCA; fibrinogen; INR; creatinine; CRP; BNP; TSH; HbA1c; troponin; albumin; GDF15. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with aortic stenosis and a confirmed indication for TAVI, scheduled to undergo TAVI and who perform their pre-TAVI work-up in our centre will be invited to participate.
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| Name | Affiliation | Role |
|---|---|---|
| Francois Schiele, MD, PhD | CHRU Besancon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Jean Minjoz | Besançon | 25000 | France |
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| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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Blood samples will be taken and centrifuged, and plasma will be aliquoted and frozen at -80°Celsius for analysis of growth differentiation factor (GDF) 15.
| pre-procedure |
| Relationship between MoCA score and each component of the VARC2 | The relationship between the MoCA and each individual component of the VARC2 will be investigated in bivariable analysis. | At 3 months after TAVI procedure |
| D014694 |
| Ventricular Outflow Obstruction |