Clinical trial of atrial fibrillation patients comparing left atrial appendage occlusion therapy to non-vitamin K antagonist oral anticoagulants.
- A documented history of non-valvular atrial fibrillation
- CHA2DS2-VASc score ≥ 3
- Eligible for long-term NOAC therapy
The CATALYST Trial will compare treatment with Abbott's Amplatzer™ Amulet™ Left Atrial Appendage Occluder to treatment with non-vitamin K antagonist oral anticoagulants (NOACs) in patients with non-valvular atrial fibrillation at high-risk for stroke.
Amplatzer Amulet LAA Occluder CAUTION: Investigational device. Limited by federal (U.S.) law to investigational use only. Not available for sale.
Subjects will be randomized 1:1 to receive the Amplatzer Amulet Left Atrial Appendage Occluder or NOAC therapy in the CATALYST Trial. The Amulet occluder is delivered in a minimally invasive transcatheter approach through a femoral venous puncture. The Amulet occluder is introduced to the left atrium via an interatrial transseptal puncture. The lobe secures the Amulet occluder within the left atrial appendage, while the disc completely seals the appendage at the orifice.
1. The Amulet delivery system is introduced via femoral venous puncture and enters the right atrium.
3. The Amulet Occluder is guided to the left atrial appendage using echocardiography and fluoroscopy. Retention wires on the lobe secure the occluder, while the disc expands to seal the appendage orifice.
NOAC reduce the risk of stroke or systemic embolic events compared to warfarin.1 However, large trials comparing the safety and efficacy of NOACs vs LAAO therapy are lacking. Subjects randomized to NOAC therapy may be prescribed any commercialy available NOAC according to drug labeling and may switch between NOACs over the course of the trial if justified. Adherence to NOAC therapy is important to the trial, and should be expressed to the patient.
Join us in the search for treatment alternatives for non-valvular atrial fibrillation patients eligible for NOAC therapy.
MAT-2005855 v1.0 | Item approved for U.S. use only.
- Ruff CT, Giugliano RP, Braunwald E, Hoffman EB, Deenadayalu N, Ezekowitz MD, Camm AJ, Weitz JI, Lewis BS, Parkhomenko A, Yamashita T, Antman EM. Comparison of the efficacy and safety of new oral anticoagulants with warfarin in patients with atrial fibrillation: a meta-analysis of randomised trials. The Lancet. 2014;383:955-962.