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

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).

Study Overview

• Status: Completed
• Conditions: Aortic Stenosis
• Intervention / Treatment: Other: MoCA cognitive assessment

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 Type: Observational
• Enrollment (Actual): 109

Contacts and Locations

Study Locations

• France
  • Besancon, France, 25000
    • University Hospital Jean Minjoz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Study cohort; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause death	Safety outcome at 3 months as assessed by the VARC2 criteria: all-cause death	through 30 days after the TAVI procedure
Stroke	Safety outcome at 30 days as assessed by the VARC2 criteria: stroke	through 30 days after the TAVI procedure
life-threatening bleed	Safety outcome at 30 days as assessed by the VARC2 criteria: life-threatening bleed	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	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.	through 30 days after the TAVI procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time required for MoCA	Length of time required to administer the MoCA test using a tablet	At the time of MoCA completion
Biological parameters pre-procedure	Blood count; prothrombin; TCA; fibrinogen; INR; creatinine; CRP; BNP; TSH; HbA1c; troponin; albumin; GDF15.	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.	At 3 months after TAVI procedure

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Besancon
• Investigators: Principal Investigator: Francois Schiele, MD, PhD, CHRU Besançon

Study record dates

Study Major Dates

• Study Start (Actual): October 9, 2019
• Primary Completion (Actual): September 30, 2021
• Study Completion (Actual): September 30, 2021

Study Registration Dates

• First Submitted: June 20, 2019
• First Submitted That Met QC Criteria: September 21, 2020
• First Posted (Actual): September 25, 2020

Study Record Updates

• Last Update Posted (Actual): February 24, 2022
• Last Update Submitted That Met QC Criteria: February 23, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: aortic stenosis; cognitive status; transcatheter aortic valve replacement
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• Other Study ID Numbers: P/2019/417

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No