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)
Study Type
OBSERVATIONAL
Enrollment
109
cognitive assessment using the validated MoCA test administered via an application on an iPad
University Hospital Jean Minjoz
Besançon, France
All-cause death
Safety outcome at 3 months as assessed by the VARC2 criteria: all-cause death
Time frame: through 30 days after the TAVI procedure
Stroke
Safety outcome at 30 days as assessed by the VARC2 criteria: stroke
Time frame: through 30 days after the TAVI procedure
life-threatening bleed
Safety outcome at 30 days as assessed by the VARC2 criteria: life-threatening bleed
Time frame: 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
Time frame: 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.
Time frame: through 30 days after the TAVI procedure
Time required for MoCA
Length of time required to administer the MoCA test using a tablet
Time frame: At the time of MoCA completion
Biological parameters pre-procedure
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Blood count; prothrombin; TCA; fibrinogen; INR; creatinine; CRP; BNP; TSH; HbA1c; troponin; albumin; GDF15.
Time frame: 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.
Time frame: At 3 months after TAVI procedure