Prospective Evaluation of Neurocognition in Patients Undergoing Transcatheter Aortic Valve Replacement

Recruiting

• Conditions: Aortic Stenosis; Mild Cognitive Impairment
• Interventions: Other: 5 minute Montreal Cognitive Assessment (mini MoCA)

• Registration Number: NCT05614986
• Lead Sponsor: Baylor Research Institute

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.

Study Timeline

• Study Start: 2022-01-17
• Status Verified: 2022-11
• Study First Submitted: 2022-11-07
• Study First Submitted QC: 2022-11-07
• Last Update Submitted: 2022-11-07
• Study First Posted: 2022-11-14
• Last Update Posted: 2022-11-14
• Primary Completion: 2024-01-01
• Study Completion: 2024-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with Mild Cognitive Impairment Undergoing TAVR	5 minute Montreal Cognitive Assessment (mini MoCA)	Patients will be treated with standard of care. In addition, patients will complete the mini MoCA at 3 time points

Primary Outcome Measures

Name	Time	Method
Neurocognition measured by Mini MoCA at 30 days post TAVR	30 days post TAVR	Changes in neurocognition compared to baseline at 30 days

Secondary Outcome Measures

Name	Time	Method
Neurocognition measured by Mini MoCA at 6 months post TAVR	6 months post TAVR	Changes in neurocognition compared to baseline at 6 months

Trial Locations

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