NCT05614986

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2022

Typical duration for all trials

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 17, 2022

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 7, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 14, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 2, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 27, 2024

Completed
Last Updated

January 27, 2026

Status Verified

October 1, 2025

Enrollment Period

1.7 years

First QC Date

November 7, 2022

Last Update Submit

January 26, 2026

Conditions

Aortic StenosisMild Cognitive Impairment

Keywords

TAVRTranscatheter Aortic Valve Replacement

Outcome Measures

Primary Outcomes (1)

  • Neurocognition measured by Mini MoCA at 30 days post TAVR

    Changes in neurocognition compared to baseline at 30 days

    30 days post TAVR

Secondary Outcomes (1)

  • Neurocognition measured by Mini MoCA at 6 months post TAVR

    6 months post TAVR

Study Arms (1)

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

Other: 5 minute Montreal Cognitive Assessment (mini MoCA)

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

Patients with Mild Cognitive Impairment Undergoing TAVR

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients undergoing TAVR with mild cognitive impairment

You may qualify if:

  • 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

You may not qualify if:

  • \. In another research study that doesn't allow dual enrolment, or dual enrolment has not been granted.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Baylor Heart and Vascular Hospital

Dallas, Texas, 75226, United States

Location

Baylor Scott & White All Saints at Fort Worth

Fort Worth, Texas, 76104, United States

Location

Baylor Scott and White The Heart Hospital Baylor Plano

Plano, Texas, 75029, United States

Location

Baylor Scott & White Medical Center - Temple

Temple, Texas, 76508, United States

Location

Related Publications (9)

  • Auffret V, Campelo-Parada F, Regueiro A, Del Trigo M, Chiche O, Chamandi C, Allende R, Cordoba-Soriano JG, Paradis JM, De Larochelliere R, Doyle D, Dumont E, Mohammadi S, Cote M, Marrero A, Puri R, Rodes-Cabau J. Serial Changes in Cognitive Function Following Transcatheter Aortic Valve Replacement. J Am Coll Cardiol. 2016 Nov 15;68(20):2129-2141. doi: 10.1016/j.jacc.2016.08.046. Epub 2016 Sep 28.

    PMID: 27692728RESULT

  • Potluri S, Szerlip M, Al-Azizi K, Harrington K, Kodali S, Kapadia S, Lu M, Leon MB, Mack MJ. Neurocognitive Function Change in Low-Risk Patients Undergoing TAVR Versus SAVR: Insights From PARTNER-3. JACC Cardiovasc Interv. 2020 Nov 23;13(22):2713-2714. doi: 10.1016/j.jcin.2020.08.009. No abstract available.

    PMID: 33213758RESULT

  • Arevalo-Rodriguez I, Smailagic N, Roque I Figuls M, Ciapponi A, Sanchez-Perez E, Giannakou A, Pedraza OL, Bonfill Cosp X, Cullum S. Mini-Mental State Examination (MMSE) for the detection of Alzheimer's disease and other dementias in people with mild cognitive impairment (MCI). Cochrane Database Syst Rev. 2015 Mar 5;2015(3):CD010783. doi: 10.1002/14651858.CD010783.pub2.

    PMID: 25740785RESULT

  • O'Bryant SE, Humphreys JD, Smith GE, Ivnik RJ, Graff-Radford NR, Petersen RC, Lucas JA. Detecting dementia with the mini-mental state examination in highly educated individuals. Arch Neurol. 2008 Jul;65(7):963-7. doi: 10.1001/archneur.65.7.963.

    PMID: 18625866RESULT

  • Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x.

    PMID: 15817019RESULT

  • Khan MM, Herrmann N, Gallagher D, Gandell D, Fremes SE, Wijeysundera HC, Radhakrishnan S, Sun YR, Lanctot KL. Cognitive Outcomes After Transcatheter Aortic Valve Implantation: A Metaanalysis. J Am Geriatr Soc. 2018 Feb;66(2):254-262. doi: 10.1111/jgs.15123. Epub 2017 Nov 21.

    PMID: 29159840RESULT

  • Liew TM. The Optimal Short Version of Montreal Cognitive Assessment in Diagnosing Mild Cognitive Impairment and Dementia. J Am Med Dir Assoc. 2019 Aug;20(8):1055.e1-1055.e8. doi: 10.1016/j.jamda.2019.02.004. Epub 2019 Mar 23.

    PMID: 30910550RESULT

  • Wong A, Nyenhuis D, Black SE, Law LS, Lo ES, Kwan PW, Au L, Chan AY, Wong LK, Nasreddine Z, Mok V. Montreal Cognitive Assessment 5-minute protocol is a brief, valid, reliable, and feasible cognitive screen for telephone administration. Stroke. 2015 Apr;46(4):1059-64. doi: 10.1161/STROKEAHA.114.007253. Epub 2015 Feb 19.

    PMID: 25700290RESULT

  • Roalf DR, Moore TM, Wolk DA, Arnold SE, Mechanic-Hamilton D, Rick J, Kabadi S, Ruparel K, Chen-Plotkin AS, Chahine LM, Dahodwala NA, Duda JE, Weintraub DA, Moberg PJ. Defining and validating a short form Montreal Cognitive Assessment (s-MoCA) for use in neurodegenerative disease. J Neurol Neurosurg Psychiatry. 2016 Dec;87(12):1303-1310. doi: 10.1136/jnnp-2015-312723. Epub 2016 Apr 12.

    PMID: 27071646RESULT

Related Links

MeSH Terms

Conditions

Cognitive DysfunctionAortic Valve Stenosis

Interventions

Mental Status and Dementia Tests

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersAortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Neuropsychological TestsPsychological TestsBehavioral Disciplines and Activities

Study Officials

  • Srinivasa Potluri, MD

    Baylor Scott and White The Heart Hospital Plano

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 7, 2022

First Posted

November 14, 2022

Study Start

January 17, 2022

Primary Completion

October 2, 2023

Study Completion

February 27, 2024

Last Updated

January 27, 2026

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

IPD will not be shared with other researchers

Locations

US(4)