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Prospective Evaluation of Neurocognition in Patients Undergoing Transcatheter Aortic Valve Replacement

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05614986
Acronym
Neurcog TAVR
Enrollment
81
Registered
2022-11-14
Start date
2022-01-17
Completion date
2024-02-27
Last updated
2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Stenosis, Mild Cognitive Impairment

Keywords

TAVR, Transcatheter Aortic Valve Replacement

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.

Interventions

OTHER5 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

Sponsors

Baylor Research Institute
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Neurocognition measured by Mini MoCA at 30 days post TAVR30 days post TAVRChanges in neurocognition compared to baseline at 30 days

Secondary

MeasureTime frameDescription
Neurocognition measured by Mini MoCA at 6 months post TAVR6 months post TAVRChanges in neurocognition compared to baseline at 6 months

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORSrinivasa Potluri, MD

Baylor Scott and White The Heart Hospital Plano

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026