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

NCT04564534 | Completed

• 1 other identifier: P/2019/417
• Study Type: observational
• Target: 109
• Locations: 1 country
• Sites: 1

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).

Conditions

Aortic Stenosis

Keywords

transcatheter aortic valve replacement; aortic stenosis; cognitive status

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (3)

• Time required for MoCA

  At the time of MoCA completion

• Biological parameters pre-procedure

  pre-procedure

• Relationship between MoCA score and each component of the VARC2

  At 3 months after TAVI procedure

Study Arms (1)

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

Interventions

MoCA cognitive assessment OTHER

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

Study cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Aged 18 years or over
• Scheduled to undergo TAVI
• Provide informed consent
• Able to understand French

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead

Study Sites (1)

University Hospital Jean Minjoz

Besançon, 25000, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples will be taken and centrifuged, and plasma will be aliquoted and frozen at -80°Celsius for analysis of growth differentiation factor (GDF) 15.

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• Francois Schiele, MD, PhD

  CHRU Besancon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2019
• First Posted: September 25, 2020
• Study Start: October 9, 2019
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2021
• Last Updated: February 24, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)