PLUG Dementia Trial: Patients will be screened at Intermountain Medical Center and at Intermountain affiliated anticoagulation clinics in the Salt Lake City region. Patients with atrial fibrillation that undergo a standard of care, clinically approved, left atrial appendage closure will be considered for study. All patients will be followed for 24 months, and will be assessed at the 3-, 6-, 12-, 18- and 24-months post-left atrial appendage closure as well as other visits deemed necessary for clinical care. All subjects will undergo protocol-specified laboratory tests and will complete 6 standard, validated questionnaires at each follow-up visit, except at the 3-month visit when only one questionnaire will be administered. A subset of patients (n=20), will receive a cranial MRI at baseline and 24-month visit. MRI PLUG Dementia Sub-Study: In addition to the above, 20 of the 60 subjects who are selected for participation in this sub-study will receive a cranial MRI at baseline and at the 2-year (24 months) follow-up visit.
Study Type
OBSERVATIONAL
Enrollment
22
Alzheimer's Disease Assessment Scale (ADAS-cog11) and Disability Assessment for Dementia (DAD) Questionnaires
MRI at baseline and at 24 months post-enrollment for 20 sub-study participants
Intermountain Heart Institute
Murray, Utah, United States
Dementia Incidence
Incident dementia determined by a formal diagnosis by a neurologist.
Time frame: 24 months
Change in cognitive decline
Moderate cognitive decline defined as a 30% decrease in Alzheimer's Disease Assessment Scale score or those with a score \<50% or a 30% change on the Disability Assessment for Dementia.
Time frame: 24 months
Incidence of baseline micro- and macro-cerebral ischemic events (Sub-study Participants)
assess the incidence of baseline micro- and macro-cerebral ischemic events (both bleeds and clots) at the time of left atrial appendage closure and compare this with a serial study.
Time frame: 24 months
Changes in cranial MRI
Incidence of bleeding and/or clots in the brain.
Time frame: 24 months
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