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

Completed

• Conditions: Aortic Stenosis

• Registration Number: NCT04564534
• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

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)

Study Timeline

• Study First Submitted: 2019-06-20
• Study Start: 2019-10-09
• Study First Submitted QC: 2020-09-21
• Study First Posted: 2020-09-25
• Primary Completion: 2021-09-30
• Study Completion: 2021-09-30
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-23
• Last Update Posted: 2022-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 109

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
All-cause death	through 30 days after the TAVI procedure	Safety outcome at 3 months as assessed by the VARC2 criteria: all-cause death
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
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.

Secondary Outcome Measures

Name	Time	Method
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.
Biological parameters pre-procedure	pre-procedure	Blood count; prothrombin; TCA; fibrinogen; INR; creatinine; CRP; BNP; TSH; HbA1c; troponin; albumin; GDF15.

Trial Locations

Locations (1)

University Hospital Jean Minjoz; 🇫🇷 Besancon, France