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

Sponsor

Centre Hospitalier Universitaire de Besancon (Other)

Overall Status

Completed

CT.gov ID

NCT04564534

Collaborator

(none)

109

Enrollment

Location

23.7

Actual Duration (Months)

4.6

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Aortic Stenosis	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 Design

Study Type:

Observational

Actual Enrollment :

109 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Oct 9, 2019

Actual Primary Completion Date :

Sep 30, 2021

Actual Study Completion Date :

Sep 30, 2021

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

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

Time required for MoCA [At the time of MoCA completion]
Length of time required to administer the MoCA test using a tablet
Biological parameters pre-procedure [pre-procedure]
Blood count; prothrombin; TCA; fibrinogen; INR; creatinine; CRP; BNP; TSH; HbA1c; troponin; albumin; GDF15.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Jean Minjoz	Besancon		France	25000

Sponsors and Collaborators

Centre Hospitalier Universitaire de Besancon

Investigators

Principal Investigator: Francois Schiele, MD, PhD, CHRU Besancon

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Universitaire de Besancon

ClinicalTrials.gov Identifier:

NCT04564534

Other Study ID Numbers:

P/2019/417

First Posted:

Sep 25, 2020

Last Update Posted:

Feb 24, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Centre Hospitalier Universitaire de Besancon

transcatheter aortic valve replacement

aortic stenosis

cognitive status

Additional relevant MeSH terms:

Aortic Valve Stenosis

Study Results

No Results Posted as of Feb 24, 2022