An observational study in Aortic Stenosis, sponsored by Centre Hospitalier Universitaire de Besancon. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-02-24.
Sponsored by Centre Hospitalier Universitaire de Besancon · Observational
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)
985 studies on the registry are indexed under Aortic Valve Stenosis; 283 are open to participants now.
This study's enrollment of 109 is below the median of 200 across 424 observational studies indexed under Aortic Valve Stenosis.
Browse Aortic Valve Stenosis studies →Centre Hospitalier Universitaire de Besancon is the lead sponsor of 439 studies on the registry; 97 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
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
cognitive assessment using the validated MoCA test administered via an application on an iPad
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
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
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier Universitaire de Besancon