This clinical investigation is intended to evaluate the safety and effectiveness of Abbott’s AmplatzerTM AmuletTM Left Atrial Appendage (LAA) occluder device (“Amulet device”) compared to commercially available non-vitamin K antagonist oral anticoagulant (NOAC) drugs in patients with non-valvular atrial fibrillation (AF) who are at increased risk for ischemic stroke and who are tolerant of long-term NOAC therapy. The Amulet device is intended to reduce the risk of thromboembolism from the LAA in patients with non-valvular AF who are at increased risk for ischemic stroke and systemic embolism based on CHADS2 or CHA2DS2-VASc scores, and offers an alternative to oral anticoagulants (OAC) for patients recommended for anticoagulation therapy.
- Documented paroxysmal, persistent, or permanent non-valvular AF (documentation must include an electrocardiogram, Holter, or event recorder)
- At high risk of stroke or systemic embolism, defined as a CHA2DS2-VASc score of ≥ 3
- Eligible for long-term NOAC therapy
- Requires long-term OAC therapy for a condition other than AF
- Planned cardiac intervention or surgery, which is invasive or requires sedation or anesthesia, within 3 months following randomization, other than study-related procedures such as LAAO and cardiac imaging (if applicable)
- Known contraindication to, or allergic to, aspirin, clopidogrel, or OAC medication use
We expect that you will be in this research study for 60 months, or about 5 years.
You will be randomized to one of two groups. Randomization is like a coin toss in deciding which group you will be part of. One patient group will receive the Amulet device and the other patient group will receive NOAC drug therapy. There will be close to the same number of patients assigned to each of the two groups, as the study uses a “one-to-one” randomization. A computer program will decide which group you will be in.
If you are randomized to the group that receives the Amulet device, you will be asked to undergo imaging of the heart prior to the procedure. You will then be scheduled for the implant procedure.
The study requires visits for all study participants at 3-, 6-, 12-, 18-, 24-, 30-months and 3-, 4-, and 5-years after randomization. In addition, patients randomized to the Amulet device and roll-in phase patients will have implant procedure and hospital discharge visits. The 6-month, 18-month, 30-month, 3-year, 4-year, and 5-year visits may be performed over the telephone. All other visits should be in person with the study staff. The in-person visits may take a few hours; the telephone visits may take up to 30 minutes.