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

Heart Center Research, LLC
Huntsville, Alabama 35801

Arizona Cardiovascular Research Center
Phoenix, Arizona 85016

Arrhythmia Research Group
Jonesboro, Arkansas 72401

UAMS Medical Center
Little Rock, Arkansas 72205

Kaiser Permanente Los Angeles Medical Center
Los Angeles, California 90027

South Denver Cardiology Associates PC
Littleton, Colorado 80120

MedStar Washington Hospital Center
Washington, District of Columbia 20010

Baptist Medical Center
Jacksonville, Florida 32207

Emory University Hospital
Atlanta, Georgia 30322

Northwestern Memorial Hospital
Chicago, Illinois 60611

St. Vincent Hospital
Indianapolis, Indiana 46240

Kansas City Cardiac Arrhythmia Research Foundation
Overland Park, Kansas 66211

Cardiovascular Research Institute of Kansas
Wichita, Kansas 67226

Baptist Health Lexington
Lexington, Kentucky 40503

Louisiana Cardiology Associates
Baton Rouge, Louisiana 70808

Cardiovascular Institute of the South
Houma, Louisiana 70361

Tufts Medical Center
Boston, Massachusetts 02111

Spectrum Health Butterworth Hospital
Grand Rapids, Michigan 49503

St. Cloud Hospital - Central MN Heart Clinic
Saint Cloud, Minnesota 56303

Jackson Heart Clinic
Jackson, Mississippi 39216

CHI Health Creighton University Medical Center-Bergan Mercy
Omaha, Nebraska 68124

Cooper University Hospital
Camden, New Jersey 08103

Mount Sinai Hospital
New York, New York 10019

New York Presbyterian Hospital/Cornell University
New York, New York 10021

Mission Health & Hospitals
Asheville, North Carolina 28801

Hightower Clinical
Oklahoma City, Oklahoma 73102

Integris Baptist Medical Center
Oklahoma City, Oklahoma 73112

Oklahoma Heart Institute at Utica
Tulsa, Oklahoma 74104

Pinnacle Health System
Harrisburg, Pennsylvania 17105

WellSpan Health
York, Pennsylvania 17403

Roper Hospital
Charleston, South Carolina 29401

Tennova Healthcare-Turkey Creek Medical Center
Knoxville, Tennessee 37920

Vanderbilt Heart & Vascular Institute
Nashville, Tennessee 37232

Texas Cardiac Arrhythmia
Austin, Texas 78705

Baylor All Saints Medical Center at Fort Worth
Fort Worth, Texas 76104

Park Plaza Hospital
Houston, Texas 77004

Memorial Hermann Hospital
Houston, Texas 77030

The Methodist Hospital
Houston, Texas 77030

Memorial Katy Cardiology Associates
Houston, Texas 77094

The Heart Hospital Baylor Plano
Plano, Texas 75093

South Texas Cardiovascular Consultants
San Antonio, Texas 78201

Medical College of Wisconsin
Milwaukee, Wisconsin 53226

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.