Amplatzer Amulet LAAO vs. NOAC (CATALYST)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Stroke; Atrial Fibrillation; Bleeding
• Intervention / Treatment: Device: Left Atrial Appendage Occlusion (Amplatzer Amulet LAA Occluder); Drug: Non-Vitamin K Oral Antagonists

• Study Type: Interventional
• Enrollment (Estimated): 2650
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Royal Adelaide Hospital
  • Western Australia
    • Murdoch, Western Australia, Australia, 6150
      • Fiona Stanley Hospital
• Canada
  • Montreal, Canada, H1T 1C8
    • Institut de Cardiologie de Montreal (Montreal Heart Inst.)
  • Montreal, Canada, H2X 3E4
    • CHUM
  • Vancouver, Canada, V5Z 1M9
    • Vancouver General Hospital (U of BC)
  • Ontario
    • Ottawa, Ontario, Canada, K1Y 4W7
      • Ottawa Heart Institute
• Czechia
  • Prague, Czechia, 150 30
    • Nemocnice na Homolce
  • Prague, Czechia, 100 34
    • Fakultni nemocnice Kralovske Vinohrady
• Denmark
  • Aarhus, Denmark, 8200
    • Skejby University Hospital
  • Copenhagen, Denmark, 2100
    • Rigshospitalet
• France
  • Clermont-Ferrand, France, 63003
    • Chu Gabriel Montpied
  • Massy, France, 91300
    • Institute Cardio. Paris-Sud - Institut Jacques Cartier
  • Paris, France, 75014
    • Mutualiste Montsouris
  • Pessac, France, 33604
    • Hopital Haut Leveque
• Germany
  • Bad Segeberg, Germany, 23795
    • Segeberger Kliniken GmbH
  • Bonn, Germany, 53115
    • St. Marien-Hospital-Bonn
  • Frankfurt, Germany, 60389
    • Cardioangiologisches Centrum am Bethanien Krankenhaus
  • Giessen, Germany, 35392
    • Klinikum der Justus-Liebig-Universität
  • Mainz, Germany, 55131
    • Universitätsmedizin der Johannes Gutenberg-Universität Mainz
  • Munich, Germany, 81379
    • Internistisches Klinikum München SUD
  • Siegburg, Germany, 53721
    • Helios Klinikum Siegburg
  • Brandenburg
    • Berlin, Brandenburg, Germany, 12203
      • Universitätsmedizin Berlin - Campus Benjamin Franklin (CBF)
  • Schleswig-Holstein
    • Lübeck, Schleswig-Holstein, Germany, 23562
      • Universitätsklinikum Schleswig-Holstein - Campus Lübeck
• Hong Kong
  • Hong Kong, Hong Kong
    • Queen Elizabeth Hospital
  • Hong Kong, Hong Kong, 999077
    • Prince of Wales Hospital
  • Hong Kong, Hong Kong
    • The University of Hong Kong (Queen Mary Hospital)
• Italy
  • Massa, Italy, 54100
    • Fondazione Toscana Gabriele Monasterio
  • Milan, Italy, 20132
    • Ospedale San Raffaele
• Japan
  • Aichi-ken
    • Toyohashi, Aichi-ken, Japan, 441-8530
      • Toyohashi Heart Center
  • Chiba
    • Chiba, Chiba, Japan, 260-8677
      • Chiba University
  • Fukuoka
    • Kitakyushu, Fukuoka, Japan, 802-8555
      • Kokura Memorial Hospital
  • Ibaraki
    • Tsukuba, Ibaraki, Japan, 305-8576
      • University of Tsukuba Hospital
  • Kanagawa
    • Kamakura, Kanagawa, Japan, 247-8533
      • Shonan Kamakura General Hospital
  • Miyagi
    • Sendai, Miyagi, Japan, 980-0973
      • Sendai Kousei Hospital
  • Okayama-ken
    • Kurashiki-shi, Okayama-ken, Japan
      • Kurashiki Central Hospital
  • Tokyo
    • Meguro-ku, Tokyo, Japan, 153-8515
      • Toho University Ohashi Medical Center
    • Tokyo, Tokyo, Japan, 113-8519
      • Institute of Science Tokyo Hospital
• Lithuania
  • Vilnius, Lithuania, 08661
    • Vilnius University Hospital Santariskiu Klinikos
• Netherlands
  • Nieuwegein, Netherlands, 3435 CM
    • St. Antonius Ziekenhuis
• Poland
  • Lodz, Poland, 92-213
    • Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi
  • Zabrze, Poland, 41-800
    • Slaskie Centrum Chorob Serca
• Spain
  • Barcelona, Spain, 08025
    • Hospital de la Santa Creu i Sant Pau
  • Barcelona, Spain, 08036
    • Hospital Clinic i Provincial de Barcelona
  • Salamanca, Spain, 37007
    • Hospital Universitario de Salamanca
  • Madrid
    • Madrid, Madrid, Spain
      • Hospital Clinico San Carlos
• Switzerland
  • Bern, Switzerland, 3010
    • Center Inselspital Bern
  • Zurich, Switzerland, 8063
    • Stadtspital Triemli
• United Kingdom
  • Brighton, United Kingdom, BN25BE
    • The Royal Sussex County Hospital
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35249
      • University Hospital - Univ. of Alabama at Birmingham (UAB)
    • Huntsville, Alabama, United States, 35801
      • Heart Center Research, LLC
  • Arizona
    • Phoenix, Arizona, United States, 85016
      • Arizona Cardiovascular Research Center
    • Tucson, Arizona, United States, 85712
      • Tucson Medical Center
  • Arkansas
    • Jonesboro, Arkansas, United States, 72401
      • Arrhythmia Research Group
    • Little Rock, Arkansas, United States, 72205
      • UAMS Medical Center
  • California
    • La Jolla, California, United States, 92037
      • Scripps Health
    • Los Angeles, California, United States, 90027
      • Kaiser Permanente Los Angeles Medical Center
    • Pasadena, California, United States, 91109
      • Huntington Memorial Hospital
    • Sacramento, California, United States, 95819
      • Mercy Medical Group - Cardiology
  • Colorado
    • Littleton, Colorado, United States, 80120
      • South Denver Cardiology Associates PC
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20010
      • MedStar Washington Hospital Center
  • Florida
    • Altamonte Springs, Florida, United States, 32701
      • AdventHealth Florida Cardiology - Altamonte Springs
    • Jacksonville, Florida, United States, 32204
      • St. Vincent's Medical Center
    • Jacksonville, Florida, United States, 32207
      • Baptist Medical Center
    • Lake Mary, Florida, United States, 32746
      • AdventHealth Florida Cardiology - Lake Mary
    • Naples, Florida, United States, 34102
      • NCH Healthcare System
    • Orlando, Florida, United States, 32803
      • AdventHealth Orlando
    • Oviedo, Florida, United States, 32765
      • AdventHealth Florida Cardiology - Oviedo
    • Sarasota, Florida, United States, 34239
      • Sarasota Memorial Hospital
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University Hospital
    • Atlanta, Georgia, United States, 30342
      • Northside Hospital
    • Atlanta, Georgia, United States, 30342
      • St. Joseph's Hospital
    • Atlanta, Georgia, United States, 30309
      • Piedmont Heart Institute
    • Lawrenceville, Georgia, United States, 30045
      • Northside Hospital (CardioVascular Group Lawrenceville)
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern Memorial Hospital
    • Winfield, Illinois, United States, 60190
      • Central DuPage Hospital
  • Indiana
    • Fort Wayne, Indiana, United States, 46801
      • Lutheran Hospital of Indiana
    • Indianapolis, Indiana, United States, 46240
      • St. Vincent Hospital
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Kansas University Medical Center
    • Overland Park, Kansas, United States, 66211
      • Kansas City Cardiac Arrhythmia Research Foundation
    • Overland Park, Kansas, United States, 66211
      • Overland Park Mid America Cardiology
    • Wichita, Kansas, United States, 67214
      • Via Christi Regional Medical Center - St. Francis Campus
  • Kentucky
    • Lexington, Kentucky, United States, 40503
      • Baptist Health Lexington
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Our Lady of the Lake Physician Group
    • Houma, Louisiana, United States, 70361
      • Cardiovascular Institute of the South
  • Maryland
    • Baltimore, Maryland, United States, 21218
      • MedStar Union Memorial Hospital
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
    • Boston, Massachusetts, United States, 02111
      • Tufts Medical Center
  • Michigan
    • Grand Rapids, Michigan, United States, 49503
      • Spectrum Health Butterworth Hospital
  • Minnesota
    • Minneapolis, Minnesota, United States, 55417
      • VA Medical Center Minneapolis
    • Saint Cloud, Minnesota, United States, 56303
      • St. Cloud Hospital - Central MN Heart Clinic
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • Jackson Heart Clinic
  • Nebraska
    • Lincoln, Nebraska, United States, 68506
      • Bryan Heart
    • Omaha, Nebraska, United States, 68124
      • CHI Health Creighton University Medical Center-Bergan Mercy
  • New Jersey
    • Camden, New Jersey, United States, 08103
      • Cooper University Hospital
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • New Mexico Heart Institute
  • New York
    • Bay Shore, New York, United States, 11706
      • South Shore University Hospital-Northwell
    • Buffalo, New York, United States, 14203
      • Buffalo General Hospital
    • New York, New York, United States, 10019
      • Mount Sinai Hospital
    • New York, New York, United States, 10021
      • New York Presbyterian Hospital/Cornell University
    • Staten Island, New York, United States, 10305
      • Staten Island University Hospital Northwell
  • North Carolina
    • Asheville, North Carolina, United States, 28801
      • Mission Health & Hospitals
    • Raleigh, North Carolina, United States, 27607
      • NC Heart & Vascular Research
  • Ohio
    • Cincinnati, Ohio, United States, 45242
      • TriHealth Bethesda North Hospital
    • Cleveland, Ohio, United States, 44195
      • The Cleveland Clinic Foundation
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73102
      • Hightower Clinical
    • Tulsa, Oklahoma, United States, 74104
      • Oklahoma Heart Institute at Utica
  • Pennsylvania
    • Harrisburg, Pennsylvania, United States, 17105
      • Pinnacle Health System
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center
    • York, Pennsylvania, United States, 17403
      • WellSpan Health
  • South Carolina
    • Charleston, South Carolina, United States, 29401
      • Roper Hospital
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57117
      • Sanford USD Medical Center
  • Tennessee
    • Chattanooga, Tennessee, United States, 37403
      • Erlanger Medical Center
    • Knoxville, Tennessee, United States, 37920
      • Tennova Healthcare-Turkey Creek Medical Center
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt Heart & Vascular Institute
  • Texas
    • Austin, Texas, United States, 78705
      • Texas Cardiac Arrhythmia
    • Forth Worth, Texas, United States, 76104
      • Baylor All Saints Medical Center at Fort Worth
    • Houston, Texas, United States, 77030
      • The Methodist Hospital
    • Houston, Texas, United States, 77030
      • Memorial Hermann Hospital
    • Houston, Texas, United States, 77004
      • Park Plaza Hospital
    • Houston, Texas, United States, 77030
      • CHI St. Luke's Health Baylor College of Medicine Med. Ctr.
    • Houston, Texas, United States, 77094
      • Memorial Katy Cardiology Associates
    • Plano, Texas, United States, 75093
      • The Heart Hospital Baylor Plano
    • San Antonio, Texas, United States, 78201
      • Methodist Texsan Hospital
    • Shenandoah, Texas, United States, 77380
      • Heart Rhythm Associates
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Sentara Norfolk General Hospital
  • West Virginia
    • Morgantown, West Virginia, United States, 26505
      • Monongalia General Hospital
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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 ≥ 2 for men and ≥ 3 for women
• Eligible for long-term NOAC therapy
• Able to comply with the required NOAC medication regimen if randomized to the Control Group
• Able to comply with the required medication regimen post-device implant if subject is randomized to the Device Group or subject is a Roll-in
• Able to understand, and is willing to provide, written informed consent to participate in the trial, prior to any clinical investigation related procedure or assessment
• 18 years of age or older, or the age of legal consent
• Able and willing to return for required follow-up visits and assessments

Exclusion Criteria:

• 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
• Indicated for P2Y12 platelet inhibitor for >1 year post-randomization
• In the opinion of the investigator, is considered at high risk for general anesthesia and general anesthesia is planned for the study procedure
• Has undergone atrial septal defect (ASD) repair or has an ASD closure device present
• Has undergone patent foramen ovale (PFO) repair or has a PFO closure device implanted
• Is implanted with a mechanical valve prosthesis
• Is implanted with an inferior vena cava filter
• History of rheumatic or congenital mitral valve heart disease
• Has any of the customary contraindications for a percutaneous catheterization procedure (e.g. subject is too small to accommodate the ICE probe (if planned) or required catheters, or subject has active infection or bleeding disorder)
• Customary contraindications for TEE/TOE (e.g., presence of esophageal varices, esophageal stricture, or history of esophageal cancer)
• Experienced stroke or transient ischemic attack (TIA) within 90 days prior to randomization or implant procedure (as applicable)
• Underwent any cardiac or non-cardiac intervention or surgery within 30 days prior to randomization
• Underwent catheter ablation for AF or atrial flutter within 60 days prior to randomization
• Experienced myocardial infarction within 90 days prior to randomization
• New York Heart Association Class IV Congestive Heart Failure
• Left ventricular ejection fraction ≤ 30% (per most recent assessment)
• Symptomatic carotid disease (defined as > 50% lumen diameter narrowing on CTA, MRA, or TCD with symptoms of ipsilateral transient or visual TIA evidenced by amaurosis fugax, ipsilateral hemispheric TIAs or ipsilateral stroke); if subject has a history of carotid stent or endarterectomy the subject is eligible if there is < 50% lumen diameter narrowing
• Has known intracranial atherosclerosis and/or intracranial small vessel disease (defined as 6 points on the Fazekas Scale)
• Reversible cause of AF (i.e., secondary to thyroid disorders, acute alcohol intoxication, trauma, recent major surgical procedures)
• History of idiopathic or recurrent venous thromboembolism
• LAA is obliterated or surgically ligated
• Thrombocytopenia (defined as < 50,000 platelets per microliter (<50 x 10^9 /L)or anemia (defined as hemoglobin < 10 g/dL) requiring transfusions
• Hypersensitivity to any portion of the device material or individual components of the Amulet LAA occluder device (e.g., nickel allergy)
• Actively enrolled in, or plans to enroll in, a concurrent clinical study in which the active treatment arm may confound the results of this trial
• Is pregnant or breastfeeding, or pregnancy is planned during the course of the investigation
• Active endocarditis or other infection producing bacteremia
• Transient case of AF (i.e., never previously detected, provoked/induced by surgical or catheter manipulations, etc.)
• Severe renal failure (estimated glomerular filtration rate <30 ml/min/1.73m2), but not on dialysis
• Life expectancy is less than 2 years in the opinion of the Investigator
• Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the Investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow up requirements, or impact the scientific soundness of the clinical investigation results.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Device Group; Randomized to Amplatzer Amulet LAA occluder	Device: Left Atrial Appendage Occlusion (Amplatzer Amulet LAA Occluder); Implantation of an Amplatzer Amulet left atrial appendage occluder; Other Names: Amplatzer Amulet LAA Occluder
Active Comparator: Control Group; Randomized to NOAC	Drug: Non-Vitamin K Oral Antagonists; Initiation or continuation of a NOAC drug; Other Names: NOAC

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major bleeding or CRNMB events	non-inferiority	2 years
Major bleeding or CRNMB events	superiority	2 years
Disabling or fatal strokes	superiority	2 years

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Principal Investigator: Vivek Reddy, MD, Mt. Sinai Medical Center

Publications and helpful links

General Publications

• Reddy VY, Hylek E, Camm AJ, Halperin JL, Diener HC, Thaler D, Schmidt B, Hara H, Huisman MV, Price MJ, Lakkireddy D, Gage R, Zhao H, Jensen TP, Quintana M, Windecker S. Left atrial appendage occlusion versus NOACs in patients with atrial fibrillation: Rationale and design of the CATALYST Trial. Am Heart J. 2026 Feb 2:107367. doi: 10.1016/j.ahj.2026.107367. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2020
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): April 1, 2031

Study Registration Dates

• First Submitted: January 9, 2020
• First Submitted That Met QC Criteria: January 10, 2020
• First Posted (Actual): January 13, 2020

Study Record Updates

• Last Update Posted (Actual): February 10, 2026
• Last Update Submitted That Met QC Criteria: February 6, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Pathological Conditions, Signs and Symptoms; Stroke; Atrial Fibrillation; Hemorrhage; N(4)-oleylcytosine arabinoside
• Other Study ID Numbers: 10310 (Fred Hutch/University of Washington Cancer Consortium)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No