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Atrial FibrillationCATALYSTNCT04226547

Amplatzer Amulet LAAO vs. NOAC

A study testing Left Atrial Appendage Occlusion (Amplatzer Amulet LAA Occluder) and Non-Vitamin K Oral Antagonists in people with Atrial Fibrillation and Stroke, run by Abbott Medical Devices at 127 sites in 16 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atrial Fibrillation, Stroke, Bleeding
What is being tested?
Left Atrial Appendage Occlusion (Amplatzer Amulet LAA Occluder) and Non-Vitamin K Oral Antagonists
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,650 participants
Where
127 sitesin 16 countries
Study dates
7 Jul 2020to Apr 2031
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 32Show fewer
  • 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.

Trial locations and contacts

127 sites in 16 countries.

127 sites in 16 countries

United States79 sites

  • New Mexico Heart Institute

    Albuquerque, New Mexico, 87102

  • AdventHealth Florida Cardiology - Altamonte Springs

    Altamonte Springs, Florida, 32701

  • Mission Health & Hospitals

    Asheville, North Carolina, 28801

  • Piedmont Heart Institute

    Atlanta, Georgia, 30309

  • Emory University Hospital

    Atlanta, Georgia, 30322

  • Northside Hospital

    Atlanta, Georgia, 30342

  • St. Joseph's Hospital

    Atlanta, Georgia, 30342

  • Texas Cardiac Arrhythmia

    Austin, Texas, 78705

  • MedStar Union Memorial Hospital

    Baltimore, Maryland, 21218

  • Our Lady of the Lake Physician Group

    Baton Rouge, Louisiana, 70808

  • South Shore University Hospital-Northwell

    Bay Shore, New York, 11706

  • University Hospital - Univ. of Alabama at Birmingham (UAB)

    Birmingham, Alabama, 35249

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Buffalo General Hospital

    Buffalo, New York, 14203

  • Cooper University Hospital

    Camden, New Jersey, 08103

  • Roper Hospital

    Charleston, South Carolina, 29401

  • Erlanger Medical Center

    Chattanooga, Tennessee, 37403

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611

  • TriHealth Bethesda North Hospital

    Cincinnati, Ohio, 45242

  • The Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Lutheran Hospital of Indiana

    Fort Wayne, Indiana, 46801

  • Baylor All Saints Medical Center at Fort Worth

    Forth Worth, Texas, 76104

  • Spectrum Health Butterworth Hospital

    Grand Rapids, Michigan, 49503

  • Pinnacle Health System

    Harrisburg, Pennsylvania, 17105

  • Cardiovascular Institute of the South

    Houma, Louisiana, 70361

  • Park Plaza Hospital

    Houston, Texas, 77004

  • CHI St. Luke's Health Baylor College of Medicine Med. Ctr.

    Houston, Texas, 77030

  • Memorial Hermann Hospital

    Houston, Texas, 77030

  • The Methodist Hospital

    Houston, Texas, 77030

  • Memorial Katy Cardiology Associates

    Houston, Texas, 77094

  • Heart Center Research, LLC

    Huntsville, Alabama, 35801

  • St. Vincent Hospital

    Indianapolis, Indiana, 46240

  • Jackson Heart Clinic

    Jackson, Mississippi, 39216

  • St. Vincent's Medical Center

    Jacksonville, Florida, 32204

  • Baptist Medical Center

    Jacksonville, Florida, 32207

  • Arrhythmia Research Group

    Jonesboro, Arkansas, 72401

  • Kansas University Medical Center

    Kansas City, Kansas, 66160

  • Tennova Healthcare-Turkey Creek Medical Center

    Knoxville, Tennessee, 37920

  • Scripps Health

    La Jolla, California, 92037

  • AdventHealth Florida Cardiology - Lake Mary

    Lake Mary, Florida, 32746

  • Northside Hospital (CardioVascular Group Lawrenceville)

    Lawrenceville, Georgia, 30045

  • Baptist Health Lexington

    Lexington, Kentucky, 40503

  • Bryan Heart

    Lincoln, Nebraska, 68506

  • UAMS Medical Center

    Little Rock, Arkansas, 72205

  • South Denver Cardiology Associates PC

    Littleton, Colorado, 80120

  • Kaiser Permanente Los Angeles Medical Center

    Los Angeles, California, 90027

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • VA Medical Center Minneapolis

    Minneapolis, Minnesota, 55417

  • Monongalia General Hospital

    Morgantown, West Virginia, 26505

  • NCH Healthcare System

    Naples, Florida, 34102

  • Vanderbilt Heart & Vascular Institute

    Nashville, Tennessee, 37232

  • Mount Sinai Hospital

    New York, New York, 10019

  • New York Presbyterian Hospital/Cornell University

    New York, New York, 10021

  • Sentara Norfolk General Hospital

    Norfolk, Virginia, 23507

  • Hightower Clinical

    Oklahoma City, Oklahoma, 73102

  • CHI Health Creighton University Medical Center-Bergan Mercy

    Omaha, Nebraska, 68124

  • AdventHealth Orlando

    Orlando, Florida, 32803

  • Kansas City Cardiac Arrhythmia Research Foundation

    Overland Park, Kansas, 66211

  • Overland Park Mid America Cardiology

    Overland Park, Kansas, 66211

  • AdventHealth Florida Cardiology - Oviedo

    Oviedo, Florida, 32765

  • Huntington Memorial Hospital

    Pasadena, California, 91109

  • Arizona Cardiovascular Research Center

    Phoenix, Arizona, 85016

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213

  • The Heart Hospital Baylor Plano

    Plano, Texas, 75093

  • NC Heart & Vascular Research

    Raleigh, North Carolina, 27607

  • Mercy Medical Group - Cardiology

    Sacramento, California, 95819

  • St. Cloud Hospital - Central MN Heart Clinic

    Saint Cloud, Minnesota, 56303

  • Methodist Texsan Hospital

    San Antonio, Texas, 78201

  • Sarasota Memorial Hospital

    Sarasota, Florida, 34239

  • Heart Rhythm Associates

    Shenandoah, Texas, 77380

  • Sanford USD Medical Center

    Sioux Falls, South Dakota, 57117

  • Staten Island University Hospital Northwell

    Staten Island, New York, 10305

  • Tucson Medical Center

    Tucson, Arizona, 85712

  • Oklahoma Heart Institute at Utica

    Tulsa, Oklahoma, 74104

  • MedStar Washington Hospital Center

    Washington D.C., District of Columbia, 20010

  • Via Christi Regional Medical Center - St. Francis Campus

    Wichita, Kansas, 67214

  • Central DuPage Hospital

    Winfield, Illinois, 60190

  • WellSpan Health

    York, Pennsylvania, 17403

Other trials in United States

Germany9 sites

  • Segeberger Kliniken GmbH

    Bad Segeberg, 23795

  • Universitätsmedizin Berlin - Campus Benjamin Franklin (CBF)

    Berlin, Brandenburg, 12203

  • St. Marien-Hospital-Bonn

    Bonn, 53115

  • Cardioangiologisches Centrum am Bethanien Krankenhaus

    Frankfurt, 60389

  • Klinikum der Justus-Liebig-Universität

    Giessen, 35392

  • Universitätsklinikum Schleswig-Holstein - Campus Lübeck

    Lübeck, Schleswig-Holstein, 23562

  • Universitätsmedizin der Johannes Gutenberg-Universität Mainz

    Mainz, 55131

  • Internistisches Klinikum München SUD

    Munich, 81379

  • Helios Klinikum Siegburg

    Siegburg, 53721

Other trials in Germany

Japan9 sites

  • Chiba University

    Chiba, Chiba, 260-8677

  • Shonan Kamakura General Hospital

    Kamakura, Kanagawa, 247-8533

  • Kokura Memorial Hospital

    Kitakyushu, Fukuoka, 802-8555

  • Kurashiki Central Hospital

    Kurashiki-shi, Okayama-ken

  • Toho University Ohashi Medical Center

    Meguro-ku, Tokyo, 153-8515

  • Sendai Kousei Hospital

    Sendai, Miyagi, 980-0973

  • Institute of Science Tokyo Hospital

    Tokyo, Tokyo, 113-8519

  • Toyohashi Heart Center

    Toyohashi, Aichi-ken, 441-8530

  • University of Tsukuba Hospital

    Tsukuba, Ibaraki, 305-8576

Other trials in Japan

Canada4 sites

  • Institut de Cardiologie de Montreal (Montreal Heart Inst.)

    Montreal, H1T 1C8

  • CHUM

    Montreal, H2X 3E4

  • Ottawa Heart Institute

    Ottawa, Ontario, K1Y 4W7

  • Vancouver General Hospital (U of BC)

    Vancouver, V5Z 1M9

Other trials in Canada

France4 sites

  • CHU Gabriel Montpied

    Clermont-Ferrand, 63003

  • Institute Cardio. Paris-Sud - Institut Jacques Cartier

    Massy, 91300

  • Mutualiste Montsouris

    Paris, 75014

  • Hopital Haut Leveque

    Pessac, 33604

Other trials in France

Spain4 sites

  • Hospital de la Santa Creu I Sant Pau

    Barcelona, 08025

  • Hospital Clinic I Provincial de Barcelona

    Barcelona, 08036

  • Hospital Clinico San Carlos

    Madrid, Madrid

  • Hospital Universitario de Salamanca

    Salamanca, 37007

Other trials in Spain

Hong Kong3 sites

  • Prince of Wales Hospital

    Hong Kong, 999077

  • Queen Elizabeth Hospital

    Hong Kong

  • The University of Hong Kong (Queen Mary Hospital)

    Hong Kong

Other trials in Hong Kong

Australia2 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Fiona Stanley Hospital

    Murdoch, Western Australia, 6150

Other trials in Australia

Czechia2 sites

  • Fakultni nemocnice Kralovske Vinohrady

    Prague, 100 34

  • Nemocnice Na Homolce

    Prague, 150 30

Other trials in Czechia

Denmark2 sites

  • Skejby University Hospital

    Aarhus, 8200

  • Rigshospitalet

    Copenhagen, 2100

Other trials in Denmark

Italy2 sites

  • Fondazione Toscana Gabriele Monasterio

    Massa, 54100

  • Ospedale San Raffaele

    Milan, 20132

Other trials in Italy

Poland2 sites

  • Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi

    Lodz, 92-213

  • Slaskie Centrum Chorob Serca

    Zabrze, 41-800

Other trials in Poland

Switzerland2 sites

  • Center Inselspital Bern

    Bern, 3010

  • Stadtspital Triemli

    Zurich, 8063

Other trials in Switzerland

Lithuania1 site

  • Vilnius University Hospital Santariskiu Klinikos

    Vilnius, 08661

Other trials in Lithuania

Netherlands1 site

  • St. Antonius Ziekenhuis

    Nieuwegein, 3435 CM

Other trials in Netherlands

United Kingdom1 site

  • The Royal Sussex County Hospital

    Brighton, BN25BE

Other trials in United Kingdom

About this study

Official title: 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.

Being tested
Left Atrial Appendage Occlusion (Amplatzer Amulet LAA Occluder), Non-Vitamin K Oral Antagonists
Medical subject headings
Atrial Fibrillation, Stroke, Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Left Atrial Appendage Occlusion (Amplatzer Amulet LAA Occluder)Device

    Also called Amplatzer Amulet LAA Occluder

    Implantation of an Amplatzer Amulet left atrial appendage occluder

  • Non-Vitamin K Oral AntagonistsDrug

    Also called NOAC

    Initiation or continuation of a NOAC drug

Study groups in NCT04226547
Study groupRoleWhat they receive
Device GroupExperimentalRandomized to Amplatzer Amulet LAA occluder
Receives: Device: Left Atrial Appendage Occlusion (Amplatzer Amulet LAA Occluder)
Control GroupActive comparatorRandomized to NOAC
Receives: Drug: Non-Vitamin K Oral Antagonists

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Composite of ischemic stroke, systemic embolism, or cardiovascular (CV) mortality

    non-inferiority

    Measured: 2 years

  2. Major bleeding or clinically relevant non-major bleeding (CRNMB) events, excluding procedure related events

    superiority

    Measured: 2 years

  3. Composite of ischemic stroke or systemic embolism

    non-inferiority

    Measured: 3 years

Secondary outcomes (3)

  1. Major bleeding or CRNMB events

    non-inferiority

    Measured: 2 years

  2. Major bleeding or CRNMB events

    superiority

    Measured: 2 years

  3. Disabling or fatal strokes

    superiority

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jan 2020
  2. Study start7 Jul 2020
  3. Primary completionJan 2029 (estimated)
  4. Study completionApr 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
2,650 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04226547
Sponsor's protocol ID
10310
Acronym
CATALYST
Status last verified
Feb 2026
First submitted
9 Jan 2020
Last updated
10 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

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 Jun;296:107367. doi: 10.1016/j.ahj.2026.107367. Epub 2026 Feb 2.

    PubMed 41638386

Questions about this trial

What is this clinical trial studying?

A study testing Left Atrial Appendage Occlusion (Amplatzer Amulet LAA Occluder) and Non-Vitamin K Oral Antagonists in people with Atrial Fibrillation and Stroke, run by Abbott Medical Devices at 127 sites in 16 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 127 sites in United States, Germany, Japan, Canada, France and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite of ischemic stroke, systemic embolism, or cardiovascular (CV) mortality (time frame: 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04226547, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.

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Amplatzer Amulet LAAO vs. NOAC (NCT04226547) | AzTrials