Amplatzer Amulet LAAO vs. NOAC

Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 ≥ 3 - 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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Device Group
Randomized to Amplatzer Amulet LAA occluder
  • Device: Left Atrial Appendage Occlusion (Amplatzer Amulet LAA Occluder)
    Implantation of an Amplatzer Amulet left atrial appendage occluder
    Other names:
    • Amplatzer Amulet LAA Occluder
Active Comparator
Control Group
Randomized to NOAC
  • Drug: Non-Vitamin K Oral Antagonists
    Initiation or continuation of a NOAC drug
    Other names:
    • NOAC

Recruiting Locations

University Hospital - Univ. of Alabama at Birmingham (UAB)
Birmingham, Alabama 35249
Contact:
Dorothy Nieters
205-975-4387
dnieters@uabmc.edu

Heart Center Research, LLC
Huntsville, Alabama 35801
Contact:
Cindy Abath
256-519-8235
cabath@theheartcenter.md

Arizona Cardiovascular Research Center
Phoenix, Arizona 85016
Contact:
Revathy Vilasan
rvilasan@azheartrhythm.com

Tucson Medical Center
Tucson, Arizona 85712
Contact:
Mary Marsh
520-324-4143
Mary.Marsh@tmcaz.com

Arrhythmia Research Group
Jonesboro, Arkansas 72401
Contact:
Kayla Rubino
870-935-6729
krubino@dnairresearch.com

Scripps Health
La Jolla, California 92037
Contact:
Christina Nava
858-824-5244
Nava.Christina@scrippshealth.org

Kaiser Permanente Los Angeles Medical Center
Los Angeles, California 90027
Contact:
Angeline Wong
323-783-5081
angeline.a.wong@kp.org

Huntington Memorial Hospital
Pasadena, California 91109
Contact:
Sadie Seto
626-397-3882
sadie.seto@huntingtonhospital.com

Mercy Medical Group - Cardiology
Sacramento, California 95819
Contact:
Svetlana Brazhnikova
916-733-6290
svetlana.brazhnikova@commonspirit.org

University of California at San Diego (UCSD) Medical Center
San Diego, California 92103
Contact:
Taylor Buchalla
tmbuchalla@health.ucsd.edu

MedStar Washington Hospital Center
Washington, District of Columbia 20010
Contact:
Nebu Alexander
202-877-0805
Nebu.Alexander@medstar.net

AdventHealth Florida Cardiology - Altamonte Springs
Altamonte Springs, Florida 32701
Contact:
Adrienne Diaz
417-543-4000
adrienne.diaz2@adventhealth.com

St. Vincent's Medical Center
Jacksonville, Florida 32204
Contact:
Nicole Neal
904-308-1229
nicole.magnes@ascension.org

Baptist Medical Center
Jacksonville, Florida 32207
Contact:
Doran Cassidy
904-202-7218
doran.cassidy@bmcjax.com

AdventHealth Florida Cardiology - Lake Mary
Lake Mary, Florida 32746
Contact:
Adrienne Diaz
417-543-4000
adrienne.diaz2@adventhealth.com

NCH Healthcare System
Naples, Florida 34102
Contact:
Linda Pastorius
linda.pastorius@nchmd.org

AdventHealth Orlando
Orlando, Florida 32803
Contact:
Adrienne Diaz
417-543-4000
adrienne.diaz2@adventhealth.com

AdventHealth Florida Cardiology - Oviedo
Oviedo, Florida 32765
Contact:
Adrienne Diaz
417-543-4000
adrienne.diaz2@adventhealth.com

Sarasota Memorial Hospital
Sarasota, Florida 34239
Contact:
Colleen Lindner
941-917-1669
colleen-lindner@smh.com

Piedmont Heart Institute
Atlanta, Georgia 30309
Contact:
Megan Kopp
megan.kopp@piedmont.org

Emory University Hospital
Atlanta, Georgia 30322
Contact:
Cindy Barnes
678-843-6093
cynthia.barnes@emory.edu

Northside Hospital
Atlanta, Georgia 30342
Contact:
Tamara Wakhisi
404-236-8322
tamara.wakhisi@northside.com

Northside Hospital (CardioVascular Group Lawrenceville)
Lawrenceville, Georgia 30045
Contact:
Tamara Wakhisi
404-236-8322
tamara.wakhisi@northside.com

Northwestern Memorial Hospital
Chicago, Illinois 60611
Contact:
Amy Carswell
312-926-7554
amy.carswell@nm.org

Rush University Medical Center
Chicago, Illinois 60612
Contact:
Nusrat Jahan
312-942-1630
Nusrat_Jahan@rush.edu

Central DuPage Hospital
Winfield, Illinois 60190
Contact:
Shameela Othman
630-938-2995
shameela.khan@nm.org

Lutheran Hospital of Indiana
Fort Wayne, Indiana 46801
Contact:
Terrie Ross
260-458-3580
tross2@lhn.net

St. Vincent Hospital
Indianapolis, Indiana 46240
Contact:
Elias Reisman
317-583-6114
elias.reisman@ascension.org

Kansas University Medical Center
Kansas City, Kansas 66160
Contact:
Denetta Nelson
913-588-9679
dnelson14@kumc.edu

Kansas City Cardiac Arrhythmia Research Foundation
Overland Park, Kansas 66211
Contact:
Donita Atkins
913-253-3064
Donita.atkins@hcahealthcare.com

Cardiovascular Research Institute of Kansas
Wichita, Kansas 67226
Contact:
Meredith Thunberg
316-219-4112
Meredith.thunberg@cckheart.com

Baptist Health Lexington
Lexington, Kentucky 40503
Contact:
Julie Ayers
859-260-4484
julie.ayers@bhsi.com

Louisiana Cardiology Associates
Baton Rouge, Louisiana 70808
Contact:
Gretchen Figarola
225-765-7659
Gretchen.Figarola@fmolhs.org

Cardiovascular Institute of the South
Houma, Louisiana 70361
Contact:
Jennifer Aucoin
985-873-5037
jennifer.aucoin@cardio.com

MedStar Union Memorial Hospital
Baltimore, Maryland 21218
Contact:
Keith Moyer
443-278-9170
keith.t.moyer@medstar.net

Tufts Medical Center
Boston, Massachusetts 02111
Contact:
Jamie Rubinstein, MD
617-636-7537
jamie.rubinstein@tuftsmedicine.org

Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215
Contact:
Jenifer Kaufman
617-632-8956
jmkaufma@bidmc.harvard.edu

Spectrum Health Butterworth Hospital
Grand Rapids, Michigan 49503
Contact:
Elizabeth Helm
616-486-2080
elizabeth.helm@spectrumhealth.org

VA Medical Center Minneapolis
Minneapolis, Minnesota 55417
Contact:
Jill Morgan
612-467-2455
Jill.Morgan2@va.gov

St. Cloud Hospital - Central MN Heart Clinic
Saint Cloud, Minnesota 56303
Contact:
Peggy Dahl
320-251-2700
dahlp@centracare.com

Jackson Heart Clinic
Jackson, Mississippi 39216
Contact:
Jamie Neal
601-982-7850
jneal@jacksonheart.com

CHI Health Creighton University Medical Center-Bergan Mercy
Omaha, Nebraska 68124
Contact:
Mel Romsa
402-343-8535
mel.romsa@chihealth.com

Cooper University Hospital
Camden, New Jersey 08103
Contact:
Claire Fisher
856-342-2000
fisher-claire@CooperHealth.edu

New Mexico Heart Institute
Albuquerque, New Mexico 87102
Contact:
Alexandra Ortiz
Alexandra.Ortiz@lovelace.com

Buffalo General Hospital
Buffalo, New York 14203
Contact:
Courtney Bishop
716-888-4839
cabishop@buffalo.edu

Mount Sinai Hospital
New York, New York 10019
Contact:
Carla Perdomo Silva
212-241-5214
Carla.perdomosilva@mountsinai.org

New York Presbyterian Hospital/Cornell University
New York, New York 10021
Contact:
Rose Spuhler
212-746-4620
ros4026@med.cornell.edu

Mission Health & Hospitals
Asheville, North Carolina 28801
Contact:
Olivia Lim
828-274-6000
Olivia.Lim@HCAHealthcare.com

NC Heart & Vascular Research
Raleigh, North Carolina 27607
Contact:
Penny Robinson
919-784-3476
penny.robinson@unchealth.unc.edu

TriHealth Bethesda North Hospital
Cincinnati, Ohio 45242
Contact:
Laurie Freel
513-865-1148
Laurie_Freel@trihealth.com

The Cleveland Clinic Foundation
Cleveland, Ohio 44195
Contact:
Kathleen Davey
daveyk@ccf.org

Hightower Clinical
Oklahoma City, Oklahoma 73102
Contact:
Lily Bobbitt
405-479-8331
lily@hightowerclinical.com

Oklahoma Heart Institute at Utica
Tulsa, Oklahoma 74104
Contact:
Lynette Tramell
Lynette.Tramell@oklahomaheart.com

Pinnacle Health System
Harrisburg, Pennsylvania 17105
Contact:
Matthew Rutt
717-531-8521
ruttmd4@upmc.edu

University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania 15213
Contact:
Susan Sweeny
412-864-1420
sweenysm@upmc.edu

WellSpan Health
York, Pennsylvania 17403
Contact:
Christine Shaeffer
717-851-3905
cshaeffer@wellspan.org

Roper Hospital
Charleston, South Carolina 29401
Contact:
Zachary Lynett
513-295-2875
zachary.lynett@accellacare.com

Sanford USD Medical Center
Sioux Falls, South Dakota 57117
Contact:
Ashley Puetz
605-328-1379
ashley.puetz@sanfordhealth.org

Erlanger Medical Center
Chattanooga, Tennessee 37403
Contact:
Parvathikumari Kasa
423-208-0106
Parvathikumari.Kasa@erlanger.org

Tennova Healthcare-Turkey Creek Medical Center
Knoxville, Tennessee 37920
Contact:
Beth Polk
865-218-7535
beth.polk@tennova.com

Vanderbilt Heart & Vascular Institute
Nashville, Tennessee 37232
Contact:
Jaime Rich
jaime.rich@vumc.org

Texas Cardiac Arrhythmia
Austin, Texas 78705
Contact:
Deb Cardinal
512-522-9410
dscardinal@austinheartbeat.com

Baylor All Saints Medical Center at Fort Worth
Fort Worth, Texas 76104
Contact:
Kristina Perez
817-922-2570
kristina.perez@bswhealth.org

Park Plaza Hospital
Houston, Texas 77004
Contact:
Brianna De Roche
713-416-2070
Brianna.DeRoche@hcahealthcare.com

CHI St. Luke's Health Baylor College of Medicine Med. Ctr.
Houston, Texas 77030
Contact:
Stephen Harold
harold@bcm.edu

Memorial Hermann Hospital
Houston, Texas 77030
Contact:
Anna Menezes
713-500-6569
Anna.M.Menezes@uth.tmc.edu

The Methodist Hospital
Houston, Texas 77030
Contact:
Chinwe Ngumezi
346-238-0290
ccngumezi@houstonmethodist.org

Memorial Katy Cardiology Associates
Houston, Texas 77094
Contact:
Madeline Peek
mpeek@practice-leadership.com

The Heart Hospital Baylor Plano
Plano, Texas 75093
Contact:
Lucy Knight
469-814-4727
Lucy.Knight@BSWHealth.org

Methodist Texsan Hospital
San Antonio, Texas 78201
Contact:
Jayla Hatcher
254-423-4059
jayla.hatcher@hcahealthcare.com

Sentara Norfolk General Hospital
Norfolk, Virginia 23507
Contact:
Linette Klevan
757-434-4286
Lrklevan@sentara.com

Medical College of Wisconsin
Milwaukee, Wisconsin 53226
Contact:
Elizabeth Jeanes
414-955-6901
ejeanes@mcw.edu

More Details

NCT ID
NCT04226547
Status
Recruiting
Sponsor
Abbott Medical Devices

Study Contact

CATALYST Study Team
(408) 845-0536
catalyststudy@abbott.com