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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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
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 ≥ 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.

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 4049979, Alabama 4829764 35249
Contact:
Wanda Hall
(205) 934-9354
wandahall@uabmc.edu

Heart Center Research, LLC
Huntsville 4068590, Alabama 4829764 35801
Contact:
Cindy Abath
(256) 519-8235
cabath@theheartcenter.md

Arizona Cardiovascular Research Center
Phoenix 5308655, Arizona 5551752 85016
Contact:
Rajashekhar Ittedi
rittedi@azcrf.org

Tucson Medical Center
Tucson 5318313, Arizona 5551752 85712
Contact:
Morgan Torrez
(520) 324-4143
Morgan.Torrez@tmcaz.com

Arrhythmia Research Group
Jonesboro 4116834, Arkansas 4099753 72401
Contact:
Kayla Rubino
(870) 340-7387
krubino@dnairresearch.com

Scripps Health
La Jolla 5363943, California 5332921 92037
Contact:
Christina Nava
(858) 824-5244
Nava.Christina@scrippshealth.org

Kaiser Permanente Los Angeles Medical Center
Los Angeles 5368361, California 5332921 90027
Contact:
Angeline Wong
(323) 783-5081
angeline.a.wong@kp.org

Huntington Memorial Hospital
Pasadena 5381396, California 5332921 91109
Contact:
Sadie Seto
(626) 397-3882
sadie.seto@huntingtonhospital.com

Mercy Medical Group - Cardiology
Sacramento 5389489, California 5332921 95819
Contact:
Svetlana Brazhnikova
(916) 733-6290
svetlana.brazhnikova@commonspirit.org

MedStar Washington Hospital Center
Washington D.C. 4140963, District of Columbia 4138106 20010
Contact:
Keith Moyer
(443) 278-9170
keith.t.moyer@medstar.net

AdventHealth Florida Cardiology - Altamonte Springs
Altamonte Springs 4145941, Florida 4155751 32701
Contact:
Jose Marquez
Omar.Marquez@AdventHealth.com

St. Vincent's Medical Center
Jacksonville 4160021, Florida 4155751 32204
Contact:
Nicole Neal
(904) 308-1229
nicole.magnes@ascension.org

Baptist Medical Center
Jacksonville 4160021, Florida 4155751 32207
Contact:
Doran Cassidy
(904) 202-7218
doran.cassidy@bmcjax.com

AdventHealth Florida Cardiology - Lake Mary
Lake Mary 4161373, Florida 4155751 32746
Contact:
Jose Marquez
Omar.Marquez@AdventHealth.com

NCH Healthcare System
Naples 4165565, Florida 4155751 34102
Contact:
Linda Pastorius
linda.pastorius@nchmd.org

AdventHealth Orlando
Orlando 4167147, Florida 4155751 32803
Contact:
Jose Marquez
Omar.Marquez@AdventHealth.com

AdventHealth Florida Cardiology - Oviedo
Oviedo 4167348, Florida 4155751 32765
Contact:
Jose Marquez
Omar.Marquez@AdventHealth.com

Sarasota Memorial Hospital
Sarasota 4172131, Florida 4155751 34239
Contact:
Rachael Sanacore
(941) 917-6568
rachael-sanacore@smh.com

Piedmont Heart Institute
Atlanta 4180439, Georgia 4197000 30309
Contact:
Megan Kopp
(404) 605-2371
megan.kopp@piedmont.org

Emory University Hospital
Atlanta 4180439, Georgia 4197000 30322
Contact:
Jovita Brevard
(404) 712-5592
jovita.johnson@emory.edu

Northside Hospital
Atlanta 4180439, Georgia 4197000 30342
Contact:
Tamara Wakhisi
(404) 236-8322
tamara.wakhisi@northside.com

St. Joseph's Hospital
Atlanta 4180439, Georgia 4197000 30342
Contact:
Jovita Brevard
(404) 712-5592
jovita.johnson@emory.edu

Northside Hospital (CardioVascular Group Lawrenceville)
Lawrenceville 4205196, Georgia 4197000 30045
Contact:
Tamara Wakhisi
(404) 236-8322
tamara.wakhisi@northside.com

Northwestern Memorial Hospital
Chicago 4887398, Illinois 4896861 60611
Contact:
Neal George
neal.george@nm.org

Central DuPage Hospital
Winfield 4916826, Illinois 4896861 60190
Contact:
Shameela Othman
(630) 938-2995
shameela.khan@nm.org

Lutheran Hospital of Indiana
Fort Wayne 4920423, Indiana 4921868 46801
Contact:
Terrie Ross
260-458-3580
tross2@lhn.net

Kansas University Medical Center
Kansas City 4273837, Kansas 4273857 66160
Contact:
Denetta Nelson
(913) 588-9679
dnelson14@kumc.edu

Kansas City Cardiac Arrhythmia Research Foundation
Overland Park 4276873, Kansas 4273857 66211
Contact:
Donita Atkins
913-253-3064
Donita.atkins@hcahealthcare.com

Overland Park Mid America Cardiology
Overland Park 4276873, Kansas 4273857 66211
Contact:
Denetta Nelson
(913) 588-9679
dnelson14@kumc.edu

Via Christi Regional Medical Center - St. Francis Campus
Wichita 4281730, Kansas 4273857 67214
Contact:
Meredith Thunberg
(316) 268-8093
meredith.thunberg@ascension.org

Baptist Health Lexington
Lexington 4297983, Kentucky 6254925 40503
Contact:
Julie Ayers
(859) 260-4484
julie.ayers@bhsi.com

Our Lady of the Lake Physician Group
Baton Rouge 4315588, Louisiana 4331987 70808
Contact:
Gretchen Figarola
(225) 765-7659
Gretchen.Figarola@fmolhs.org

Cardiovascular Institute of the South
Houma 4328010, Louisiana 4331987 70361
Contact:
Vicky Parfait
(985) 873-5603
vicky.parfait@cardio.com

MedStar Union Memorial Hospital
Baltimore 4347778, Maryland 4361885 21218
Contact:
Keith Moyer
(443) 278-9170
keith.t.moyer@medstar.net

Tufts Medical Center
Boston 4930956, Massachusetts 6254926 02111
Contact:
Jamie Rubinstein, MD
(617) 636-7537
jamie.rubinstein@tuftsmedicine.org

Beth Israel Deaconess Medical Center
Boston 4930956, Massachusetts 6254926 02215
Contact:
Jenifer Kaufman
(617) 632-8956
jmkaufma@bidmc.harvard.edu

Spectrum Health Butterworth Hospital
Grand Rapids 4994358, Michigan 5001836 49503
Contact:
Elizabeth Helm
(616) 486-2080
elizabeth.helm@spectrumhealth.org

VA Medical Center Minneapolis
Minneapolis 5037649, Minnesota 5037779 55417
Contact:
Jill Morgan
612-467-2455
Jill.Morgan2@va.gov

St. Cloud Hospital - Central MN Heart Clinic
Saint Cloud 5044407, Minnesota 5037779 56303
Contact:
Audrey Hillenbrand-Raap
(320) 251-2700
audrey.hillenbrand-raap@centracare.com

Jackson Heart Clinic
Jackson 4431410, Mississippi 4436296 39216
Contact:
Jamie Neal
(601) 982-7850
jneal@jacksonheart.com

Bryan Heart
Lincoln 5072006, Nebraska 5073708 68506
Contact:
Nicci Thompson
(402) 483-3290
nicci.thompson@bryanheart.com

CHI Health Creighton University Medical Center-Bergan Mercy
Omaha 5074472, Nebraska 5073708 68124
Contact:
Mel Romsa
(402) 343-8535
mel.romsa@commonspirit.org

Cooper University Hospital
Camden 4501018, New Jersey 5101760 08103
Contact:
Claire Fisher
(856) 342-2000
fisher-claire@CooperHealth.edu

New Mexico Heart Institute
Albuquerque 5454711, New Mexico 5481136 87102
Contact:
Zinai Tellez
(505) 843-2827
Zinai.Tellez@lovelace.com

South Shore University Hospital-Northwell
Bay Shore 5108169, New York 5128638 11706
Contact:
Rachel Gentles
(631) 968-3016
Rgentles1@northwell.edu

Buffalo General Hospital
Buffalo 5110629, New York 5128638 14203
Contact:
Courtney Bishop
(716) 888-4839
cabishop@buffalo.edu

Mount Sinai Hospital
New York 5128581, New York 5128638 10019
Contact:
Shahryar Kamran
Shahryar.Kamran@mountsinai.org

New York Presbyterian Hospital/Cornell University
New York 5128581, New York 5128638 10021
Contact:
Rose Spuhler
(212) 746-4620
ros4026@med.cornell.edu

Staten Island University Hospital Northwell
Staten Island 5139568, New York 5128638 10305
Contact:
Alexandra Pantea
(718) 226-6438
apantea@northwell.edu

Mission Health & Hospitals
Asheville 4453066, North Carolina 4482348 28801
Contact:
Olivia Lim
(828) 274-6000
Olivia.Lim@HCAHealthcare.com

NC Heart & Vascular Research
Raleigh 4487042, North Carolina 4482348 27607
Contact:
Penny Robinson
(919) 784-3476
penny.robinson@unchealth.unc.edu

TriHealth Bethesda North Hospital
Cincinnati 4508722, Ohio 5165418 45242
Contact:
Laurie Freel
(513) 865-1148
Laurie_Freel@trihealth.com

The Cleveland Clinic Foundation
Cleveland 5150529, Ohio 5165418 44195
Contact:
Alexis Lilly
216-445-5617
lillya4@ccf.org

Hightower Clinical
Oklahoma City 4544349, Oklahoma 4544379 73102
Contact:
Zac Johnson
(405) 666-0884
zac@hightowerclinical.com

Oklahoma Heart Institute at Utica
Tulsa 4553433, Oklahoma 4544379 74104
Contact:
Loyce Keeton
loyce.chintsanyakeeton@hillcrest.com

Pinnacle Health System
Harrisburg 5192726, Pennsylvania 6254927 17105
Contact:
Matthew Rutt
(717) 531-8521
ruttmd4@upmc.edu

University of Pittsburgh Medical Center
Pittsburgh 5206379, Pennsylvania 6254927 15213
Contact:
Susan Sweeny
(412) 864-1420
sweenysm@upmc.edu

WellSpan Health
York 4562407, Pennsylvania 6254927 17403
Contact:
Christine Shaeffer
(717) 851-3905
cshaeffer@wellspan.org

Roper Hospital
Charleston 4574324, South Carolina 4597040 29401
Contact:
Zachary Lynett
(513) 295-2875
zachary.lynett@accellacare.com

Sanford USD Medical Center
Sioux Falls 5231851, South Dakota 5769223 57117
Contact:
Mitchell Lonneman
(605) 318-1360
mitchell.lonneman2@sanfordhealth.org

Erlanger Medical Center
Chattanooga 4612862, Tennessee 4662168 37403
Contact:
Parvathikumari Kasa
4232080106
Parvathikumari.Kasa@erlanger.org

Tennova Healthcare-Turkey Creek Medical Center
Knoxville 4634946, Tennessee 4662168 37920
Contact:
Beth Polk
(865) 218-7535
beth.polk@tennova.com

Vanderbilt Heart & Vascular Institute
Nashville 4644585, Tennessee 4662168 37232
Contact:
Jaime Rich
jaime.rich@vumc.org

Texas Cardiac Arrhythmia
Austin 4671654, Texas 4736286 78705
Contact:
Deb Cardinal
(512) 522-9410
dscardinal@austinheartbeat.com

Baylor All Saints Medical Center at Fort Worth
Forth Worth, Texas 4736286 76104
Contact:
Kristina Perez
(817) 922-2570
kristina.perez@bswhealth.org

Park Plaza Hospital
Houston 4699066, Texas 4736286 77004
Contact:
Swathi Potla
(832) 986-8280
swathi.potla@hcahealthcare.com

Memorial Hermann Hospital
Houston 4699066, Texas 4736286 77030
Contact:
Anna Menezes
Anna.M.Menezes@uth.tmc.edu

The Methodist Hospital
Houston 4699066, Texas 4736286 77030
Contact:
Aneesch Martin
(713) 441-6539
admartin@houstonmethodist.org

Memorial Katy Cardiology Associates
Houston 4699066, Texas 4736286 77094
Contact:
Madeline Peek
mpeek@practice-leadership.com

The Heart Hospital Baylor Plano
Plano 4719457, Texas 4736286 75093
Contact:
Emmitt Lavergne
Emmitt.Lavergne@BSWHealth.org

Methodist Texsan Hospital
San Antonio 4726206, Texas 4736286 78201
Contact:
Jayla Hatcher
(254) 423-4059
jayla.hatcher@hcahealthcare.com

Heart Rhythm Associates
Shenandoah 4728287, Texas 4736286 77380
Contact:
Jessica Riddle
(936) 537-8088
jriddle@woodlandshra.com

Sentara Norfolk General Hospital
Norfolk 4776222, Virginia 6254928 23507
Contact:
Linette Klevan
(757) 434-4286
Lrklevan@sentara.com

Monongalia General Hospital
Morgantown 4815352, West Virginia 4826850 26505
Contact:
Keri Yokopovich
Keri.Yokopovich@vandaliahealth.org

Medical College of Wisconsin
Milwaukee 5263045, Wisconsin 5279468 53226
Contact:
Miranda Johnson
mijohnson@mcw.edu

More Details

NCT ID
NCT04226547
Status
Recruiting
Sponsor
Abbott Medical Devices

Study Contact

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.