Do you suffer from atrial fibrillation? Commonly known as Afib, atrial fibrillation is by far the most common form of heart arrhythmia, affecting millions of Americans. The condition occurs when there are erratic electrical signals between the upper chambers of the heart, or atria. As a result, the heart fibrillates, or quivers, resulting in sub-optimal pumping of the atria and can ultimately lead to very serious and even life-threatening complications. Blood can pool and form clots, especially in the left atrial appendage where more than 90% of clots originate in patients with Afib. AFib patients have a risk of death from cardiovascular complications that is double that of the general population and a stroke risk that is five times higher.
About the Trial
The Abbott CATALYST Trial is a clinical trial to compare left atrial appendage occlusion therapy to non-vitamin K antagonist oral anticoagulants (NOACs) (“blood thinners”) in patients with non-valvular atrial fibrillation at high-risk for stroke. Delivered to the heart by accessing a vein in the upper leg, the Amplatzer™ Amulet™ left atrial appendage occlusion device allows physicians to permanently “seal off” the left atrial appendage, thus reducing the risk of blood clots being released and potentially causing a stroke. The trial is evaluating if the Amulet device may be a viable alternative to a lifetime of blood thinners.
Current guidelines for managing Afib patients (JACC 2019. 74(1):104-132) state left atrial appendage occlusion may be considered for patients with atrial fibrillation at increased risk of stroke who have contraindications to long-term anticoagulation. Similarly, Medicare only covers commercial left atrial appendage occlusion as a second line therapy to anticoagulation in patients unable to take long-term anticoagulation. The CATALYST Trial will evaluate the safety and effectiveness of left atrial appendage occlusion in atrial fibrillation patients who are good candidates for long-term NOAC blood thinners, thus not currently recommended or covered for commercial left atrial appendage occlusion.
NOACs reduce the risk of stroke or systemic embolic events compared to the previous class of blood thinners called warfarin. However, large randomized trials comparing the safety and effectiveness of the newer NOACs vs. left atrial appendage occlusion therapy are lacking.
Are You Eligible?
We are actively recruiting and screening patients who may be eligible for this study. Patients with a documented history of non-valvular atrial fibrillation who are eligible for long-term NOAC therapy, and meeting other enrollment criteria, will be randomized 1:1 to either receive the Amplatzer Amulet Left Atrial Appendage Occluder or NOAC therapy and followed for five years in the trial. The Amulet occluder is delivered in a minimally-invasive transcatheter approach through a vein in the upper leg. The Amulet occluder is introduced to the left atrium and appendage by crossing the heart wall between the upper chambers. The Amulet lobe secures the occluder within the left atrial appendage, while the Amulet disc completely seals the appendage at the entry to the appendage (depicted in the figures below).
Important Inclusion Criteria
- A documented history of non-valvular atrial fibrillation
- CHA2DS2-VASc score greater than or equal to 3
- Eligible for long-term NOAC therapy
Important Exclusion Criteria
- Patient requires long-term OAC therapy for a condition other than AF
- Planned cardiac intervention or surgery within 3 months following randomization
- Known contraindications to, or allergic to, aspirin, clopidogrel, or OAC medication use
If you are interested in this trial and want to know if you qualify, please contact the CIS Houma Research Department at 1-800-445-9676.