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Completed

NCT Number: NCT05614986

Prospective Evaluation of Neurocognition in Patients Undergoing Transcatheter Aortic Valve Replacement

This trail is for patients with mild cognitive impairment (MCI) who are receiving a transcatheter aortic valve replacement (TAVR). We will assess changes in neurocognition following TAVR with the 5 minute Montreal Cognitive Assessment (mini MoCA) when comparing pre procedure with post procedure assessments.

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Key information

Conditions

Mild Cognitive Impairment Aortic Stenosis Aortic Valve Disease Aortic Valve Stenosis Cardiovascular Diseases Cognition Disorders Cognitive Dysfunction Heart Diseases Heart Valve Diseases Mental Disorders Neurocognitive Disorders Ventricular Outflow Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Baylor Heart and Vascular Hospital, Dallas, Texas, United States

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About this study

Patients with mild cognitive impairment who are being treated with a TAVR can choose to take part in this trial. This trial will prospectively enroll patients at 4 Baylor Scott & White facilities. 80 patients will be enrolled between all sites. The mini MoCA will be conducted at the following time points: pre TAVR, 30 days post TAVR, and 6 months post TAVR. All other data will be collected from patient charts and are considered standard part of their care.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 18 years or older
  • Undergoing a TAVR procedure
  • Possible MCI as determined by procedures already used in the TAVR clinics, including 1 of the 4:
  • MMSE < 27
  • History of MCI, dementia, or stroke (CVA or TIA)
  • History of prescription treatment for MCI
  • Discretion of the investigator, physician, or clinic staff
  • Scores 25 or less on the mini MoCA exam

Exclusion criteria

  • In another research study that doesn't allow dual enrolment, or dual enrolment has not been granted.

Treatment and study plan

5 minute Montreal Cognitive Assessment (mini MoCA)

Other

The mini MoCA will be completed by the patient before TAVR, and 30 days and 6 months after TAVR

Primary outcomes

  1. Neurocognition measured by Mini MoCA at 30 days post TAVR

    Time frame: 30 days post TAVR

    Changes in neurocognition compared to baseline at 30 days

Secondary outcomes

  1. Neurocognition measured by Mini MoCA at 6 months post TAVR

    Time frame: 6 months post TAVR

    Changes in neurocognition compared to baseline at 6 months

Sponsors and collaborators

Lead sponsor

Baylor Research Institute

Other

Registry information

Official study title

Prospective Evaluation of Neurocognition in Patients Undergoing Transcatheter Aortic Valve Replacement: Periprocedural Changes and Predictors of Improvement

Acronym: Neurcog TAVR

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Nov 14, 2022
Registry last updated
Jan 27, 2026

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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