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 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

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

UAMS Medical Center
Little Rock, Arkansas 72205
Contact:
Sushma Dugyala
501-603-1268
sdugyala@UAMS.edu

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:
Elizabeth Castorena
323-783-5830
elizabeth.castorena@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:
Christie Hogan
916-453-4575
christie.hogan@commonspirit.org

South Denver Cardiology Associates PC
Littleton, Colorado 80120
Contact:
Mary Soltau
303-703-2191
msoltau@southdenver.com

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

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

NCH Healthcare System
Naples, Florida 34102
Contact:
Kathy Byrd
239-624-8113
Kathy.Byrd@nchmd.org

AdventHealth Orlando
Orlando, Florida 32803
Contact:
Daniel Robledo
407-303-5600
Daniel.Robledo@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:
Nino Kavtaradze
404-593-8922
nkavtar@emory.edu

Northside Hospital
Atlanta, Georgia 30342
Contact:
Kathleen Sutter
404-962-2379
Kathleen.Sutter2@northside.com

Northwestern Memorial Hospital
Chicago, Illinois 60611
Contact:
Amy Carswell
312-926-7554
amy.carswell@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:
Barbara Kingma
317-583-6319
Barbara.Kingma@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:
Lindsey Steele
316-219-4125
lindsey.steele@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

Tufts Medical Center
Boston, Massachusetts 02111
Contact:
Vilma Castaneda, MD
617-636-7537
VCastaneda@tuftsmedicalcenter.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:
Emerson Clement
856-342-2000
Clement-Emerson@Cooperhealth.edu

New Mexico Heart Institute
Albuquerque, New Mexico 87102
Contact:
Deanna Garcia
505-843-2804
deanna.garcia@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:
Stephanie Harcum
347-744-8844
Stephanie.harcum@mountsinai.org

New York Presbyterian Hospital/Cornell University
New York, New York 10021
Contact:
Patricia Encarnacion
212-746-4620
pme2003@med.cornell.edu

Mission Health & Hospitals
Asheville, North Carolina 28801
Contact:
Phoebe Castelblanco
828-213-3961
Phoebe.JollayCastelblanco@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:
Anne Voorhorst
513-865-1148
Anne_Voorhorst@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

Integris Baptist Medical Center
Oklahoma City, Oklahoma 73112
Contact:
Melissa Adams
405-949-4020
melissa.adams2@integrisok.com

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

Pinnacle Health System
Harrisburg, Pennsylvania 17105
Contact:
Dawn MacFarlane
717-731-0101
macfarlanedm@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:
Teri Rebert
717-851-3713
trebert@wellspan.org

Roper Hospital
Charleston, South Carolina 29401
Contact:
Joshua Burgess
843-849-1880
joshua.burgess@accellacare.com

Sanford USD Medical Center
Sioux Falls, South Dakota 57117
Contact:
Diana Ibarra Garcia
diana.ibarragarcia@sanfordhealth.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:
Amanda Carroll
615-936-1293
amanda.carroll@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:
Hoan Morrison
832-633-5463
joan.morrison@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:
Mary Pierce
713-486-1934
Mary.H.Pierce@uth.tmc.edu

The Methodist Hospital
Houston, Texas 77030
Contact:
Maria Del Pino
832-212-1947
mdelpino@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

South Texas Cardiovascular Consultants
San Antonio, Texas 78201
Contact:
Jodie Addington
210-635-1690
JAddington@TxHeartHealth.Net

Medical College of Wisconsin
Milwaukee, Wisconsin 53226
Contact:
Mary Wexler
414-955-6741
mwexler@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.