Amplatzer Amulet LAAO Vs. NOAC
- Conditions
- Atrial FibrillationStrokeBleeding
- Interventions
- Drug: Non-Vitamin K Oral AntagonistsDevice: Left Atrial Appendage Occlusion (Amplatzer Amulet LAA Occluder)
- Registration Number
- NCT04226547
- Lead Sponsor
- Abbott Medical Devices
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 2650
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Group Non-Vitamin K Oral Antagonists Randomized to NOAC Device Group Left Atrial Appendage Occlusion (Amplatzer Amulet LAA Occluder) Randomized to Amplatzer Amulet LAA occluder
- Primary Outcome Measures
Name Time Method Composite of ischemic stroke, systemic embolism, or cardiovascular (CV) mortality 2 years non-inferiority
Major bleeding or clinically relevant non-major bleeding (CRNMB) events, excluding procedure related events 2 years superiority
Composite of ischemic stroke or systemic embolism 3 years non-inferiority
- Secondary Outcome Measures
Name Time Method Major bleeding or CRNMB events 2 years superiority
Disabling or fatal strokes 2 years superiority
Trial Locations
- Locations (132)
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
University of California at San Diego (UCSD) Medical Center
🇺🇸San Diego, California, United States
South Denver Cardiology Associates PC
🇺🇸Littleton, Colorado, United States
MedStar Washington Hospital Center
🇺🇸Washington, 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
Rush University Medical Center
🇺🇸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
Integris Baptist Medical Center
🇺🇸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
Royal Melbourne Hospital - City Campus
🇦🇺Parkville, Australia
Ottawa Heart Institute
🇨🇦Ottawa, Ontario, Canada
Institut de Cardiologie de Montreal (Montreal Heart Inst.)
🇨🇦Montréal, Canada
CHUM
🇨🇦Montréal, Canada
Vancouver General Hospital (U of BC)
🇨🇦Vancouver, Canada
Fakultni nemocnice Kralovske Vinohrady
🇨🇿Prague, Czechia
Nemocnice Na Homolce
🇨🇿Prague, Czechia
Skejby University Hospital
🇩🇰Arhus, Denmark
Rigshospitalet
🇩🇰Copenhagen, Denmark
CHU Gabriel Montpied
🇫🇷Clermont-Ferrand, France
Hopital Henri Mondor
🇫🇷Créteil, 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
🇮🇹Milano, Italy
Toyohashi Heart Center
🇯🇵Toyohashi, Aichi, Japan
Chiba University
🇯🇵Chiba-shi, 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, Japan
Toho University Ohashi Medical Center
🇯🇵Meguro-ku, Tokyo, Japan
Institute of Science Tokyo Hospital
🇯🇵Tokyo, Japan
Vilnius University Hospital Santariskiu Klinikos
🇱🇹Vilnius, Lithuania
St. Antonius Ziekenhuis
🇳🇱Nieuwegein, Netherlands
Slaskie Centrum Chorob Serca
🇵🇱Zabrze, Poland
Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi
🇵🇱Łódź, Poland
Hospital Clinico San Carlos
🇪🇸Madrid, Community of 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
🇨🇭Zürich, Switzerland
The Royal Sussex County Hospital
🇬🇧Brighton, United Kingdom