CATALYST Trial

The aim of this trial is to assess both the safety and effectiveness of the Amulet Left Atrial Appendage (LAA) occluder in comparison to Non-Vitamin K Antagonist Oral Anticoagulant (NOAC) therapy. This evaluation specifically targets patients with non-valvular atrial fibrillation (AF) who are at an elevated risk for ischemic stroke and are recommended to undergo long-term NOAC therapy.

In order to participate you must meet the following criteria:

• Are 18 years of age or older.
• Have documented paroxysmal, persistent, or permanent non-valvular AF (documentation must include an electrocardiogram, Holter, or event recorder).
• Are at high risk of stroke or systemic embolism, defined as a CHA2DS2-VASc score of ≥ 3.
• Are eligible for long-term NOAC therapy.

You will be excluded from the study if any of the following criteria apply to you:

• Require long-term OAC therapy for a condition other than AF.
• Have 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).
• Have known contraindication to, or allergic to, aspirin, clopidogrel, or OAC medication use.

This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.