Impact of Pre-procedure Cognitive Status on Outcome at 3 Months After Transcatheter Aortic Valve Implantation

Study Overview
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Brief Summary
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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).

Detailed Description
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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)

Official Title
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Impact of Pre-procedure Cognitive Status on Outcome at 3 Months After Transcatheter Aortic Valve Implantation

Conditions
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Aortic Stenosis

Intervention / Treatment
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* Other: MoCA cognitive assessment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 18 years or over Scheduled to undergo TAVI Provide informed consent Able to understand French Exclusion Criteria: subjects under legal guardianship or other legal protection subjects with documented severe dementia subjects with anticipated poor compliance subjects unable to understand French sufficiently well to perform the MoCA test pregnant women subjects within the exclusion period of another study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study cohort<br>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. | Other: MoCA cognitive assessment<br>* cognitive assessment using the validated MoCA test administered via an application on an iPad<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cognitive status, transcatheter aortic valve replacement, aortic stenosis