Prospective Evaluation of Neurocognition in Patients Undergoing Transcatheter Aortic Valve Replacement

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

81 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-17

Study Completion Date

2024-02-27

Brief Summary

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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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Detailed Description

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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.

Conditions

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Mild Cognitive Impairment Aortic Stenosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

5 minute Montreal Cognitive Assessment (mini MoCA)

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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