Prospective Evaluation of Neurocognition in Patients Undergoing Transcatheter Aortic Valve Replacement (Neurcog TAVR)

January 26, 2026 updated by: Baylor Research Institute

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

81

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75226
        • Baylor Heart and Vascular Hospital
      • Fort Worth, Texas, United States, 76104
        • Baylor Scott & White All Saints at Fort Worth
      • Plano, Texas, United States, 75029
        • Baylor Scott and White The Heart Hospital Baylor Plano
      • Temple, Texas, United States, 76508
        • Baylor Scott & White Medical Center - Temple

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients undergoing TAVR with mild cognitive impairment

Description

Inclusion Criteria:

  1. Age 18 years or older
  2. Undergoing a TAVR procedure

  3. Possible MCI as determined by procedures already used in the TAVR clinics, including 1 of the 4:

    1. MMSE < 27
    2. History of MCI, dementia, or stroke (CVA or TIA)
    3. History of prescription treatment for MCI
    4. Discretion of the investigator, physician, or clinic staff
  4. Scores 25 or less on the mini MoCA exam

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with Mild Cognitive Impairment Undergoing TAVR
Patients will be treated with standard of care. In addition, patients will complete the mini MoCA at 3 time points
Other: 5 minute Montreal Cognitive Assessment (mini MoCA)
The mini MoCA will be completed by the patient before TAVR, and 30 days and 6 months after TAVR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
30 days post TAVR

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months post TAVR

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baylor Research Institute

Investigators

  • Principal Investigator: Srinivasa Potluri, MD, Baylor Scott and White The Heart Hospital Plano

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 17, 2022

Primary Completion (Actual)

October 2, 2023

Study Completion (Actual)

February 27, 2024

Study Registration Dates

First Submitted

November 7, 2022

First Submitted That Met QC Criteria

November 7, 2022

First Posted (Actual)

November 14, 2022

Study Record Updates

Last Update Posted (Actual)

January 27, 2026

Last Update Submitted That Met QC Criteria

January 26, 2026

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 021-262

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD will not be shared with other researchers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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