NCT03091855

PLUG Dementia Trial and MRI PLUG Dementia Sub-Study

Overall and MRI-based Impact of Percutaneous Left Atrial Appendage Closure on the Cognitive Decline and Dementia in Patients With Atrial Fibrillation (PLUG Dementia Trial and MRI PLUG Dementia Sub-Study)

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 22 (actual)
• Sponsor: Intermountain Health Care, Inc. · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Atrial Fibrillation
• Dementia
• Cognitive Decline

Interventions

Type	Name	Description
OTHER	Questionnaire	Alzheimer's Disease Assessment Scale (ADAS-cog11) and Disability Assessment for Dementia (DAD) Questionnaires
DIAGNOSTIC_TEST	Magnetic Resonance Imaging	MRI at baseline and at 24 months post-enrollment for 20 sub-study participants

Timeline

• Start date: 2017-04-03
• Primary completion: 2021-01-08
• Completion: 2021-01-08
• First posted: 2017-03-27
• Last updated: 2021-04-05

Locations

1 site across 1 country: United States