Prospective Evaluation of Neurocognition in Patients Undergoing Transcatheter Aortic Valve Replacement

Baylor Research Institute81 enrolled

Overview

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.

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

Conditions

Mild Cognitive Impairment Aortic Stenosis

Interventions

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (4)

Baylor Heart and Vascular Hospital

Dallas, Texas, United States

Baylor Scott & White All Saints at Fort Worth

Fort Worth, Texas, United States

Baylor Scott and White The Heart Hospital Baylor Plano

Plano, Texas, United States

Baylor Scott & White Medical Center - Temple

Temple, Texas, United States

Outcomes

Primary Outcomes

Neurocognition measured by Mini MoCA at 30 days post TAVR

Changes in neurocognition compared to baseline at 30 days

Time frame: 30 days post TAVR

Secondary Outcomes

Neurocognition measured by Mini MoCA at 6 months post TAVR

Changes in neurocognition compared to baseline at 6 months

Time frame: 6 months post TAVR

Data from ClinicalTrials.gov

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