Aortic Stenosis
Conditions
Keywords
transcatheter aortic valve replacement, aortic stenosis, cognitive status
Brief summary
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
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)
Interventions
OTHERMoCA cognitive assessment
cognitive assessment using the validated MoCA test administered via an application on an iPad
Sponsors
Centre Hospitalier Universitaire de Besancon
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Combined VARC2 efficacy outcome | through 30 days after the TAVI procedure | 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. |
| Stroke | through 30 days after the TAVI procedure | Safety outcome at 30 days as assessed by the VARC2 criteria: stroke |
| life-threatening bleed | through 30 days after the TAVI procedure | Safety outcome at 30 days as assessed by the VARC2 criteria: life-threatening bleed |
| Combined VARC2 safety outcome | through 30 days after the TAVI procedure | 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 |
| All-cause death | through 30 days after the TAVI procedure | Safety outcome at 3 months as assessed by the VARC2 criteria: all-cause death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Biological parameters pre-procedure | pre-procedure | Blood count; prothrombin; TCA; fibrinogen; INR; creatinine; CRP; BNP; TSH; HbA1c; troponin; albumin; GDF15. |
| Time required for MoCA | At the time of MoCA completion | Length of time required to administer the MoCA test using a tablet |
| Relationship between MoCA score and each component of the VARC2 | At 3 months after TAVI procedure | The relationship between the MoCA and each individual component of the VARC2 will be investigated in bivariable analysis. |
Countries
France
Outcome results
None listed