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ACTIVE NOT RECRUITING

NCT04226547

Amplatzer Amulet LAAO vs. NOAC

Sponsor: Abbott Medical Devices

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

2650

Start Date

2020-07-07

Completion Date

2031-04

Last Updated

2026-02-10

Healthy Volunteers

Conditions

Atrial Fibrillation Stroke Bleeding

Interventions

DEVICE

Left Atrial Appendage Occlusion (Amplatzer Amulet LAA Occluder)

Implantation of an Amplatzer Amulet left atrial appendage occluder

DRUG

Non-Vitamin K Oral Antagonists

Initiation or continuation of a NOAC drug

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.

Locations (127)

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

Clinical Research Directory

Amplatzer Amulet LAAO vs. NOAC

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (127)