Amplatzer Amulet LAAO vs. NOAC

NCT04226547 | Active Not Recruiting DMC FDA Device

• 1 other identifier: 10310
• Study Type: interventional
• Target: 2,650
• Locations: 16 countries
• Sites: 127

Brief 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. 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.

Conditions

Atrial Fibrillation; Stroke; Bleeding

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Major bleeding or CRNMB events

  2 years

• Major bleeding or CRNMB events

  2 years

• Disabling or fatal strokes

  2 years

Study Arms (2)

Device Group

EXPERIMENTAL

Randomized to Amplatzer Amulet LAA occluder

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

Control Group

ACTIVE COMPARATOR

Randomized to NOAC

Drug: Non-Vitamin K Oral Antagonists

Interventions

Non-Vitamin K Oral Antagonists DRUG

Initiation or continuation of a NOAC drug

Also known as: NOAC

Control Group

Left Atrial Appendage Occlusion (Amplatzer Amulet LAA Occluder) DEVICE

Implantation of an Amplatzer Amulet left atrial appendage occluder

Also known as: Amplatzer Amulet LAA Occluder

Device Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• years of age or older, or the age of legal consent
• Able and willing to return for required follow-up visits and assessments

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (127)

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

Birmingham, Alabama, 35249, United States

Location

Heart Center Research, LLC

Huntsville, Alabama, 35801, United States

Location

Arizona Cardiovascular Research Center

Phoenix, Arizona, 85016, United States

Location

Tucson Medical Center

Tucson, Arizona, 85712, United States

Location

Arrhythmia Research Group

Jonesboro, Arkansas, 72401, United States

Location

UAMS Medical Center

Little Rock, Arkansas, 72205, United States

Location

Scripps Health

La Jolla, California, 92037, United States

Location

Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, 90027, United States

Location

Huntington Memorial Hospital

Pasadena, California, 91109, United States

Location

Mercy Medical Group - Cardiology

Sacramento, California, 95819, United States

Location

South Denver Cardiology Associates PC

Littleton, Colorado, 80120, United States

Location

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

AdventHealth Florida Cardiology - Altamonte Springs

Altamonte Springs, Florida, 32701, United States

Location

St. Vincent's Medical Center

Jacksonville, Florida, 32204, United States

Location

Baptist Medical Center

Jacksonville, Florida, 32207, United States

Location

AdventHealth Florida Cardiology - Lake Mary

Lake Mary, Florida, 32746, United States

Location

NCH Healthcare System

Naples, Florida, 34102, United States

Location

AdventHealth Orlando

Orlando, Florida, 32803, United States

Location

AdventHealth Florida Cardiology - Oviedo

Oviedo, Florida, 32765, United States

Location

Sarasota Memorial Hospital

Sarasota, Florida, 34239, United States

Location

Piedmont Heart Institute

Atlanta, Georgia, 30309, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Northside Hospital

Atlanta, Georgia, 30342, United States

Location

St. Joseph's Hospital

Atlanta, Georgia, 30342, United States

Location

Northside Hospital (CardioVascular Group Lawrenceville)

Lawrenceville, Georgia, 30045, United States

Location

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Central DuPage Hospital

Winfield, Illinois, 60190, United States

Location

Lutheran Hospital of Indiana

Fort Wayne, Indiana, 46801, United States

Location

St. Vincent Hospital

Indianapolis, Indiana, 46240, United States

Location

Kansas University Medical Center

Kansas City, Kansas, 66160, United States

Location

Kansas City Cardiac Arrhythmia Research Foundation

Overland Park, Kansas, 66211, United States

Location

Overland Park Mid America Cardiology

Overland Park, Kansas, 66211, United States

Location

Via Christi Regional Medical Center - St. Francis Campus

Wichita, Kansas, 67214, United States

Location

Baptist Health Lexington

Lexington, Kentucky, 40503, United States

Location

Our Lady of the Lake Physician Group

Baton Rouge, Louisiana, 70808, United States

Location

Cardiovascular Institute of the South

Houma, Louisiana, 70361, United States

Location

MedStar Union Memorial Hospital

Baltimore, Maryland, 21218, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Spectrum Health Butterworth Hospital

Grand Rapids, Michigan, 49503, United States

Location

VA Medical Center Minneapolis

Minneapolis, Minnesota, 55417, United States

Location

St. Cloud Hospital - Central MN Heart Clinic

Saint Cloud, Minnesota, 56303, United States

Location

Jackson Heart Clinic

Jackson, Mississippi, 39216, United States

Location

Bryan Heart

Lincoln, Nebraska, 68506, United States

Location

CHI Health Creighton University Medical Center-Bergan Mercy

Omaha, Nebraska, 68124, United States

Location

Cooper University Hospital

Camden, New Jersey, 08103, United States

Location

New Mexico Heart Institute

Albuquerque, New Mexico, 87102, United States

Location

South Shore University Hospital-Northwell

Bay Shore, New York, 11706, United States

Location

Buffalo General Hospital

Buffalo, New York, 14203, United States

Location

Mount Sinai Hospital

New York, New York, 10019, United States

Location

New York Presbyterian Hospital/Cornell University

New York, New York, 10021, United States

Location

Staten Island University Hospital Northwell

Staten Island, New York, 10305, United States

Location

Mission Health & Hospitals

Asheville, North Carolina, 28801, United States

Location

NC Heart & Vascular Research

Raleigh, North Carolina, 27607, United States

Location

TriHealth Bethesda North Hospital

Cincinnati, Ohio, 45242, United States

Location

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Hightower Clinical

Oklahoma City, Oklahoma, 73102, United States

Location

Oklahoma Heart Institute at Utica

Tulsa, Oklahoma, 74104, United States

Location

Pinnacle Health System

Harrisburg, Pennsylvania, 17105, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

WellSpan Health

York, Pennsylvania, 17403, United States

Location

Roper Hospital

Charleston, South Carolina, 29401, United States

Location

Sanford USD Medical Center

Sioux Falls, South Dakota, 57117, United States

Location

Erlanger Medical Center

Chattanooga, Tennessee, 37403, United States

Location

Tennova Healthcare-Turkey Creek Medical Center

Knoxville, Tennessee, 37920, United States

Location

Vanderbilt Heart & Vascular Institute

Nashville, Tennessee, 37232, United States

Location

Texas Cardiac Arrhythmia

Austin, Texas, 78705, United States

Location

Baylor All Saints Medical Center at Fort Worth

Forth Worth, Texas, 76104, United States

Location

Park Plaza Hospital

Houston, Texas, 77004, United States

Location

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

Houston, Texas, 77030, United States

Location

Memorial Hermann Hospital

Houston, Texas, 77030, United States

Location

The Methodist Hospital

Houston, Texas, 77030, United States

Location

Memorial Katy Cardiology Associates

Houston, Texas, 77094, United States

Location

The Heart Hospital Baylor Plano

Plano, Texas, 75093, United States

Location

Methodist Texsan Hospital

San Antonio, Texas, 78201, United States

Location

Heart Rhythm Associates

Shenandoah, Texas, 77380, United States

Location

Sentara Norfolk General Hospital

Norfolk, Virginia, 23507, United States

Location

Monongalia General Hospital

Morgantown, West Virginia, 26505, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

Fiona Stanley Hospital

Murdoch, Western Australia, 6150, Australia

Location

Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

Location

Institut de Cardiologie de Montreal (Montreal Heart Inst.)

Montreal, H1T 1C8, Canada

Location

CHUM

Montreal, H2X 3E4, Canada

Location

Vancouver General Hospital (U of BC)

Vancouver, V5Z 1M9, Canada

Location

Fakultni nemocnice Kralovske Vinohrady

Prague, 100 34, Czechia

Location

Nemocnice Na Homolce

Prague, 150 30, Czechia

Location

Skejby University Hospital

Aarhus, 8200, Denmark

Location

Rigshospitalet

Copenhagen, 2100, Denmark

Location

CHU Gabriel Montpied

Clermont-Ferrand, 63003, France

Location

Institute Cardio. Paris-Sud - Institut Jacques Cartier

Massy, 91300, France

Location

Mutualiste Montsouris

Paris, 75014, France

Location

Hopital Haut Leveque

Pessac, 33604, France

Location

Universitätsmedizin Berlin - Campus Benjamin Franklin (CBF)

Berlin, Brandenburg, 12203, Germany

Location

Universitätsklinikum Schleswig-Holstein - Campus Lübeck

Lübeck, Schleswig-Holstein, 23562, Germany

Location

Segeberger Kliniken GmbH

Bad Segeberg, 23795, Germany

Location

St. Marien-Hospital-Bonn

Bonn, 53115, Germany

Location

Cardioangiologisches Centrum am Bethanien Krankenhaus

Frankfurt, 60389, Germany

Location

Klinikum der Justus-Liebig-Universität

Giessen, 35392, Germany

Location

Universitätsmedizin der Johannes Gutenberg-Universität Mainz

Mainz, 55131, Germany

Location

Internistisches Klinikum München SUD

Munich, 81379, Germany

Location

Helios Klinikum Siegburg

Siegburg, 53721, Germany

Location

Prince of Wales Hospital

Hong Kong, 999077, Hong Kong

Location

Queen Elizabeth Hospital

Hong Kong, Hong Kong

Location

The University of Hong Kong (Queen Mary Hospital)

Hong Kong, Hong Kong

Location

Fondazione Toscana Gabriele Monasterio

Massa, 54100, Italy

Location

Ospedale San Raffaele

Milan, 20132, Italy

Location

Toyohashi Heart Center

Toyohashi, Aichi-ken, 441-8530, Japan

Location

Chiba University

Chiba, Chiba, 260-8677, Japan

Location

Kokura Memorial Hospital

Kitakyushu, Fukuoka, 802-8555, Japan

Location

University of Tsukuba Hospital

Tsukuba, Ibaraki, 305-8576, Japan

Location

Shonan Kamakura General Hospital

Kamakura, Kanagawa, 247-8533, Japan

Location

Sendai Kousei Hospital

Sendai, Miyagi, 980-0973, Japan

Location

Kurashiki Central Hospital

Kurashiki-shi, Okayama-ken, Japan

Location

Toho University Ohashi Medical Center

Meguro-ku, Tokyo, 153-8515, Japan

Location

Institute of Science Tokyo Hospital

Tokyo, Tokyo, 113-8519, Japan

Location

Vilnius University Hospital Santariskiu Klinikos

Vilnius, 08661, Lithuania

Location

St. Antonius Ziekenhuis

Nieuwegein, 3435 CM, Netherlands

Location

Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi

Lodz, 92-213, Poland

Location

Slaskie Centrum Chorob Serca

Zabrze, 41-800, Poland

Location

Hospital Clinico San Carlos

Madrid, Madrid, Spain

Location

Hospital de la Santa Creu I Sant Pau

Barcelona, 08025, Spain

Location

Hospital Clinic I Provincial de Barcelona

Barcelona, 08036, Spain

Location

Hospital Universitario de Salamanca

Salamanca, 37007, Spain

Location

Center Inselspital Bern

Bern, 3010, Switzerland

Location

Stadtspital Triemli

Zurich, 8063, Switzerland

Location

The Royal Sussex County Hospital

Brighton, BN25BE, United Kingdom

Location

Related Publications (1)

• 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;296:107367. doi: 10.1016/j.ahj.2026.107367. Online ahead of print.

  PMID: 41638386 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation; Stroke; Hemorrhage

Interventions

N(4)-oleylcytosine arabinoside

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Study Officials

• Vivek Reddy, MD

  Mt. Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2020
• First Posted: January 13, 2020
• Study Start: July 7, 2020
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): April 1, 2031
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CH (2); US (79); ES (4); HK (3); CZ (2); JP (9); GB (1); NL (1); CA (4); DK (2); DE (9); IT (2); PL (2); AU (2); FR (4); LI (1)