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

Aortic Stenosis Clinical Trial

— TAVI-Geriatrie  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04564534
• Other study ID #: P/2019/417
• Status: Completed
• Start date: October 9, 2019
• Est. completion date: September 30, 2021

Study information

• Verified date: February 2022
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: September 30, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Stenosis
• Aortic Valve Stenosis

Intervention

Other:
• MoCA cognitive assessment
cognitive assessment using the validated MoCA test administered via an application on an iPad

Locations

Country	Name	City	State
France	University Hospital Jean Minjoz	Besancon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause death	Safety outcome at 3 months as assessed by the VARC2 criteria: all-cause death	through 30 days after the TAVI procedure
Primary	Stroke	Safety outcome at 30 days as assessed by the VARC2 criteria: stroke	through 30 days after the TAVI procedure
Primary	life-threatening bleed	Safety outcome at 30 days as assessed by the VARC2 criteria: life-threatening bleed	through 30 days after the TAVI procedure
Primary	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
Primary	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	Time required for MoCA	Length of time required to administer the MoCA test using a tablet	At the time of MoCA completion
Secondary	Biological parameters pre-procedure	Blood count; prothrombin; TCA; fibrinogen; INR; creatinine; CRP; BNP; TSH; HbA1c; troponin; albumin; GDF15.	pre-procedure
Secondary	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