Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
2650 participants
INTERVENTIONAL
2020-07-07
2031-04-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Device Group
Randomized to Amplatzer Amulet LAA occluder
Left Atrial Appendage Occlusion (Amplatzer Amulet LAA Occluder)
Implantation of an Amplatzer Amulet left atrial appendage occluder
Control Group
Randomized to NOAC
Non-Vitamin K Oral Antagonists
Initiation or continuation of a NOAC drug
Interventions
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Left Atrial Appendage Occlusion (Amplatzer Amulet LAA Occluder)
Implantation of an Amplatzer Amulet left atrial appendage occluder
Non-Vitamin K Oral Antagonists
Initiation or continuation of a NOAC drug
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Abbott Medical Devices
INDUSTRY
Responsible Party
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Principal Investigators
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Vivek Reddy, MD
Role: PRINCIPAL_INVESTIGATOR
Mt. Sinai Medical Center
Locations
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University Hospital - Univ. of Alabama at Birmingham (UAB)
Birmingham, Alabama, United States
Heart Center Research, LLC
Huntsville, Alabama, United States
Arizona Cardiovascular Research Center
Phoenix, Arizona, United States
Tucson Medical Center
Tucson, Arizona, United States
Arrhythmia Research Group
Jonesboro, Arkansas, United States
UAMS Medical Center
Little Rock, Arkansas, United States
Scripps Health
La Jolla, California, United States
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States
Huntington Memorial Hospital
Pasadena, California, United States
Mercy Medical Group - Cardiology
Sacramento, California, United States
South Denver Cardiology Associates PC
Littleton, Colorado, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
AdventHealth Florida Cardiology - Altamonte Springs
Altamonte Springs, Florida, United States
St. Vincent's Medical Center
Jacksonville, Florida, United States
Baptist Medical Center
Jacksonville, Florida, United States
AdventHealth Florida Cardiology - Lake Mary
Lake Mary, Florida, United States
NCH Healthcare System
Naples, Florida, United States
AdventHealth Orlando
Orlando, Florida, United States
AdventHealth Florida Cardiology - Oviedo
Oviedo, Florida, United States
Sarasota Memorial Hospital
Sarasota, Florida, United States
Piedmont Heart Institute
Atlanta, Georgia, United States
Emory University Hospital
Atlanta, Georgia, United States
Northside Hospital
Atlanta, Georgia, United States
St. Joseph's Hospital
Atlanta, Georgia, United States
Northside Hospital (CardioVascular Group Lawrenceville)
Lawrenceville, Georgia, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
Central DuPage Hospital
Winfield, Illinois, United States
Lutheran Hospital of Indiana
Fort Wayne, Indiana, United States
St. Vincent Hospital
Indianapolis, Indiana, United States
Kansas University Medical Center
Kansas City, Kansas, United States
Kansas City Cardiac Arrhythmia Research Foundation
Overland Park, Kansas, United States
Overland Park Mid America Cardiology
Overland Park, Kansas, United States
Via Christi Regional Medical Center - St. Francis Campus
Wichita, Kansas, United States
Baptist Health Lexington
Lexington, Kentucky, United States
Our Lady of the Lake Physician Group
Baton Rouge, Louisiana, United States
Cardiovascular Institute of the South
Houma, Louisiana, United States
MedStar Union Memorial Hospital
Baltimore, Maryland, United States
Tufts Medical Center
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Spectrum Health Butterworth Hospital
Grand Rapids, Michigan, United States
VA Medical Center Minneapolis
Minneapolis, Minnesota, United States
St. Cloud Hospital - Central MN Heart Clinic
Saint Cloud, Minnesota, United States
Jackson Heart Clinic
Jackson, Mississippi, United States
Bryan Heart
Lincoln, Nebraska, United States
CHI Health Creighton University Medical Center-Bergan Mercy
Omaha, Nebraska, United States
Cooper University Hospital
Camden, New Jersey, United States
New Mexico Heart Institute
Albuquerque, New Mexico, United States
South Shore University Hospital-Northwell
Bay Shore, New York, United States
Buffalo General Hospital
Buffalo, New York, United States
Mount Sinai Hospital
New York, New York, United States
New York Presbyterian Hospital/Cornell University
New York, New York, United States
Staten Island University Hospital Northwell
Staten Island, New York, United States
Mission Health & Hospitals
Asheville, North Carolina, United States
NC Heart & Vascular Research
Raleigh, North Carolina, United States
TriHealth Bethesda North Hospital
Cincinnati, Ohio, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, United States
Hightower Clinical
Oklahoma City, Oklahoma, United States
Oklahoma Heart Institute at Utica
Tulsa, Oklahoma, United States
Pinnacle Health System
Harrisburg, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
WellSpan Health
York, Pennsylvania, United States
Roper Hospital
Charleston, South Carolina, United States
Sanford USD Medical Center
Sioux Falls, South Dakota, United States
Erlanger Medical Center
Chattanooga, Tennessee, United States
Tennova Healthcare-Turkey Creek Medical Center
Knoxville, Tennessee, United States
Vanderbilt Heart & Vascular Institute
Nashville, Tennessee, United States
Texas Cardiac Arrhythmia
Austin, Texas, United States
Baylor All Saints Medical Center at Fort Worth
Forth Worth, Texas, United States
Park Plaza Hospital
Houston, Texas, United States
CHI St. Luke's Health Baylor College of Medicine Med. Ctr.
Houston, Texas, United States
Memorial Hermann Hospital
Houston, Texas, United States
The Methodist Hospital
Houston, Texas, United States
Memorial Katy Cardiology Associates
Houston, Texas, United States
The Heart Hospital Baylor Plano
Plano, Texas, United States
Methodist Texsan Hospital
San Antonio, Texas, United States
Heart Rhythm Associates
Shenandoah, Texas, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, United States
Monongalia General Hospital
Morgantown, West Virginia, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Fiona Stanley Hospital
Murdoch, Western Australia, Australia
Ottawa Heart Institute
Ottawa, Ontario, Canada
Institut de Cardiologie de Montreal (Montreal Heart Inst.)
Montreal, , Canada
CHUM
Montreal, , Canada
Vancouver General Hospital (U of BC)
Vancouver, , Canada
Fakultni nemocnice Kralovske Vinohrady
Prague, , Czechia
Nemocnice Na Homolce
Prague, , Czechia
Skejby University Hospital
Aarhus, , Denmark
Rigshospitalet
Copenhagen, , Denmark
CHU Gabriel Montpied
Clermont-Ferrand, , France
Institute Cardio. Paris-Sud - Institut Jacques Cartier
Massy, , France
Mutualiste Montsouris
Paris, , France
Hopital Haut Leveque
Pessac, , France
Universitätsmedizin Berlin - Campus Benjamin Franklin (CBF)
Berlin, Brandenburg, Germany
Universitätsklinikum Schleswig-Holstein - Campus Lübeck
Lübeck, Schleswig-Holstein, Germany
Segeberger Kliniken GmbH
Bad Segeberg, , Germany
St. Marien-Hospital-Bonn
Bonn, , Germany
Cardioangiologisches Centrum am Bethanien Krankenhaus
Frankfurt, , Germany
Klinikum der Justus-Liebig-Universität
Giessen, , Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, , Germany
Internistisches Klinikum München SUD
Munich, , Germany
Helios Klinikum Siegburg
Siegburg, , Germany
Prince of Wales Hospital
Hong Kong, , Hong Kong
Queen Elizabeth Hospital
Hong Kong, , Hong Kong
The University of Hong Kong (Queen Mary Hospital)
Hong Kong, , Hong Kong
Fondazione Toscana Gabriele Monasterio
Massa, , Italy
Ospedale San Raffaele
Milan, , Italy
Toyohashi Heart Center
Toyohashi, Aichi-ken, Japan
Chiba University
Chiba, Chiba, Japan
Kokura Memorial Hospital
Kitakyushu, Fukuoka, Japan
University of Tsukuba Hospital
Tsukuba, Ibaraki, Japan
Shonan Kamakura General Hospital
Kamakura, Kanagawa, Japan
Sendai Kousei Hospital
Sendai, Miyagi, Japan
Kurashiki Central Hospital
Kurashiki-shi, Okayama-ken, Japan
Toho University Ohashi Medical Center
Meguro-ku, Tokyo, Japan
Institute of Science Tokyo Hospital
Tokyo, Tokyo, Japan
Vilnius University Hospital Santariskiu Klinikos
Vilnius, , Lithuania
St. Antonius Ziekenhuis
Nieuwegein, , Netherlands
Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi
Lodz, , Poland
Slaskie Centrum Chorob Serca
Zabrze, , Poland
Hospital Clinico San Carlos
Madrid, Madrid, Spain
Hospital de la Santa Creu I Sant Pau
Barcelona, , Spain
Hospital Clinic I Provincial de Barcelona
Barcelona, , Spain
Hospital Universitario de Salamanca
Salamanca, , Spain
Center Inselspital Bern
Bern, , Switzerland
Stadtspital Triemli
Zurich, , Switzerland
The Royal Sussex County Hospital
Brighton, , United Kingdom
Countries
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References
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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.
Other Identifiers
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10310
Identifier Type: -
Identifier Source: org_study_id
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