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Completed

NCT Number: NCT04564534

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

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).

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Jean Minjoz

Besançon, 25000, France

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MoCA cognitive assessment

Other

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

Primary outcomes

  1. All-cause death

    Time frame: through 30 days after the TAVI procedure

    Safety outcome at 3 months as assessed by the VARC2 criteria: all-cause death

  2. Stroke

    Time frame: through 30 days after the TAVI procedure

    Safety outcome at 30 days as assessed by the VARC2 criteria: stroke

  3. life-threatening bleed

    Time frame: through 30 days after the TAVI procedure

    Safety outcome at 30 days as assessed by the VARC2 criteria: life-threatening bleed

  4. Combined VARC2 safety outcome

    Time frame: 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

  5. Combined VARC2 efficacy outcome

    Time frame: 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 outcomes

  1. Time required for MoCA

    Time frame: At the time of MoCA completion

    Length of time required to administer the MoCA test using a tablet

  2. Biological parameters pre-procedure

    Time frame: pre-procedure

    Blood count; prothrombin; TCA; fibrinogen; INR; creatinine; CRP; BNP; TSH; HbA1c; troponin; albumin; GDF15.

  3. Relationship between MoCA score and each component of the VARC2

    Time frame: At 3 months after TAVI procedure

    The relationship between the MoCA and each individual component of the VARC2 will be investigated in bivariable analysis.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Besancon

Other

Registry information

Acronym: TAVI-Geriatrie

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Sep 25, 2020
Registry last updated
Feb 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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