PLUG Dementia Trial
| Status: | Recruiting |
|---|---|
| Conditions: | Atrial Fibrillation, Cognitive Studies, Neurology |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Neurology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 65 - Any |
| Updated: | 10/20/2018 |
| Start Date: | April 3, 2017 |
| End Date: | October 2019 |
| Contact: | Patti Spencer |
| Email: | patti.spencer@imail.org |
| Phone: | 801-507-4778 |
Impact of Percutaneous Left Atrial Appendage Closure on the Cognitive Decline and Dementia in Patients With Atrial Fibrillation (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.
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.
Inclusion Criteria:
1. Male or female >65 years of age
2. Atrial fibrillation documented by electrocardiogram, ambulatory event monitor, or
telemetry within 6 months of enrollment
3. Moderate risk of thromboembolism based upon a CHADS2 score or CHADS2 Vasc score of ≥2.
4. Recipient of a left atrial appendage closure device within 3 months of enrollment
5. Have the ability to complete a mini-mental status evaluation
6. Have the ability to independently comprehend and complete a quality of life and
dementia questionnaires.
7. Ability to provide informed consent for study participation
8. Willing and able to comply with the prescribed follow-up tests and schedule of
evaluations.
Exclusion Criteria:
1. Have a history of any form of dementia
2. Have a life expectancy less than 24 months
3. Are unable to comply with the follow-up schedule
4. An upper age limit not to be used if participation inclusion criteria are met.
5. Participation in any other clinical trials involving an investigational or marketed
drug within 30 days prior to entry in this study;
6. Other conditions that in the opinion of the Principal Investigator may increase risk
to the subject and/or compromise the quality of the clinical trial
7. The Principal Investigator(s) determine(s) that the subject is not eligible for
participation in this research study.
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