Prospective Evaluation of Neurocognition in Patients Undergoing Transcatheter Aortic Valve Replacement

Study Overview
=================
Brief Summary
-----------------
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.

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.

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

Conditions
-----------------
Mild Cognitive Impairment, Aortic Stenosis

Intervention / Treatment
-----------------
* Other: 5 minute Montreal Cognitive Assessment (mini MoCA)


Participation Criteria
=================
Eligibility Criteria
-----------------
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: 1. In another research study that doesn't allow dual enrolment, or dual enrolment has not been granted.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with Mild Cognitive Impairment Undergoing TAVR<br>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)<br>* The mini MoCA will be completed by the patient before TAVR, and 30 days and 6 months after TAVR<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurocognition measured by Mini MoCA at 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 | Changes in neurocognition compared to baseline at 6 months | 6 months post TAVR | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
TAVR, Transcatheter Aortic Valve Replacement