CompletedNot Applicable

Prospective Evaluation of Neurocognition in Patients Undergoing Transcatheter Aortic Valve Replacement

United States81 participantsStarted 2022-01-17

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Neurocognition measured by Mini MoCA at 30 days post TAVR

Timeframe: 30 days post TAVR

Trial details

NCT IDNCT05614986

SponsorBaylor Research Institute

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-10-02

View on ClinicalTrials.gov More Mild Cognitive Impairment trials