Clinical Trial of Atrial Fibrillation Patients Comparing Left Atrial Appendage Occlusion Therapy to Non-vitamin K Antagonist Oral Anticoagulants (CATALYST)

NCT04226547 NA ACTIVE_NOT_RECRUITING

The objective of this trial is to evaluate the safety and effectiveness of the Amulet LAA occluder compared to NOAC therapy in patients with non-valvular AF at increased risk for ischemic stroke and who are recommended for long-term NOAC therapy. The clinical investigation is a prospective, randomized, multicenter active control worldwide trial. Subjects will be randomized in a 1:1 ratio between the Amulet LAA occlusion device ("Device Group") and a commercially available NOAC medication ("Control Group"). The choice of NOAC in the Control Group will be left to study physician discretion.

Details

Lead sponsor	Abbott Medical Devices
Phase	NA
Status	ACTIVE_NOT_RECRUITING
Enrolment	2650
Start date	2020-07-07
Completion	2031-04

Conditions

• Atrial Fibrillation
• Stroke
• Bleeding

Interventions

• Left Atrial Appendage Occlusion (Amplatzer Amulet LAA Occluder)
• Non-Vitamin K Oral Antagonists

Primary outcomes

• Composite of ischemic stroke, systemic embolism, or cardiovascular (CV) mortality — 2 years
  non-inferiority
• Major bleeding or clinically relevant non-major bleeding (CRNMB) events, excluding procedure related events — 2 years
  superiority
• Composite of ischemic stroke or systemic embolism — 3 years
  non-inferiority

Countries

United States, Australia, Canada, Czechia, Denmark, France, Germany, Hong Kong, Italy, Japan, Lithuania, Netherlands, Poland, Spain, Switzerland, United Kingdom