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 ≥ 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
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Device Group |
Randomized to Amplatzer Amulet LAA occluder |
|
|
Active Comparator Control Group |
Randomized to NOAC |
|
Recruiting Locations
University Hospital - Univ. of Alabama at Birmingham (UAB)
Birmingham, Alabama 35249
Birmingham, Alabama 35249
Heart Center Research, LLC
Huntsville, Alabama 35801
Huntsville, Alabama 35801
Arrhythmia Research Group
Jonesboro, Arkansas 72401
Jonesboro, Arkansas 72401
Scripps Health
La Jolla, California 92037
La Jolla, California 92037
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California 90027
Los Angeles, California 90027
Huntington Memorial Hospital
Pasadena, California 91109
Pasadena, California 91109
Mercy Medical Group - Cardiology
Sacramento, California 95819
Sacramento, California 95819
MedStar Washington Hospital Center
Washington, District of Columbia 20010
Washington, District of Columbia 20010
AdventHealth Florida Cardiology - Altamonte Springs
Altamonte Springs, Florida 32701
Altamonte Springs, Florida 32701
St. Vincent's Medical Center
Jacksonville, Florida 32204
Jacksonville, Florida 32204
Baptist Medical Center
Jacksonville, Florida 32207
Jacksonville, Florida 32207
AdventHealth Florida Cardiology - Lake Mary
Lake Mary, Florida 32746
Lake Mary, Florida 32746
AdventHealth Florida Cardiology - Oviedo
Oviedo, Florida 32765
Oviedo, Florida 32765
Sarasota Memorial Hospital
Sarasota, Florida 34239
Sarasota, Florida 34239
Piedmont Heart Institute
Atlanta, Georgia 30309
Atlanta, Georgia 30309
Emory University Hospital
Atlanta, Georgia 30322
Atlanta, Georgia 30322
Northside Hospital
Atlanta, Georgia 30342
Atlanta, Georgia 30342
St. Joseph's Hospital
Atlanta, Georgia 30342
Atlanta, Georgia 30342
Northside Hospital (CardioVascular Group Lawrenceville)
Lawrenceville, Georgia 30045
Lawrenceville, Georgia 30045
Central DuPage Hospital
Winfield, Illinois 60190
Winfield, Illinois 60190
Lutheran Hospital of Indiana
Fort Wayne, Indiana 46801
Fort Wayne, Indiana 46801
Kansas University Medical Center
Kansas City, Kansas 66160
Kansas City, Kansas 66160
Kansas City Cardiac Arrhythmia Research Foundation
Overland Park, Kansas 66211
Overland Park, Kansas 66211
Overland Park Mid America Cardiology
Overland Park, Kansas 66211
Overland Park, Kansas 66211
Cardiovascular Research Institute of Kansas
Wichita, Kansas 67226
Wichita, Kansas 67226
Baptist Health Lexington
Lexington, Kentucky 40503
Lexington, Kentucky 40503
Louisiana Cardiology Associates
Baton Rouge, Louisiana 70808
Baton Rouge, Louisiana 70808
Cardiovascular Institute of the South
Houma, Louisiana 70361
Houma, Louisiana 70361
MedStar Union Memorial Hospital
Baltimore, Maryland 21218
Baltimore, Maryland 21218
Tufts Medical Center
Boston, Massachusetts 02111
Boston, Massachusetts 02111
Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215
Boston, Massachusetts 02215
Spectrum Health Butterworth Hospital
Grand Rapids, Michigan 49503
Grand Rapids, Michigan 49503
VA Medical Center Minneapolis
Minneapolis, Minnesota 55417
Minneapolis, Minnesota 55417
St. Cloud Hospital - Central MN Heart Clinic
Saint Cloud, Minnesota 56303
Saint Cloud, Minnesota 56303
Jackson Heart Clinic
Jackson, Mississippi 39216
Jackson, Mississippi 39216
Bryan Heart
Lincoln, Nebraska 68506
Lincoln, Nebraska 68506
CHI Health Creighton University Medical Center-Bergan Mercy
Omaha, Nebraska 68124
Omaha, Nebraska 68124
Cooper University Hospital
Camden, New Jersey 08103
Camden, New Jersey 08103
New Mexico Heart Institute
Albuquerque, New Mexico 87102
Albuquerque, New Mexico 87102
South Shore University Hospital-Northwell
Bay Shore, New York 11706
Bay Shore, New York 11706
Buffalo General Hospital
Buffalo, New York 14203
Buffalo, New York 14203
Mount Sinai Hospital
New York, New York 10019
New York, New York 10019
New York Presbyterian Hospital/Cornell University
New York, New York 10021
New York, New York 10021
Staten Island University Hospital Northwell
Staten Island, New York 10305
Staten Island, New York 10305
Mission Health & Hospitals
Asheville, North Carolina 28801
Asheville, North Carolina 28801
NC Heart & Vascular Research
Raleigh, North Carolina 27607
Raleigh, North Carolina 27607
TriHealth Bethesda North Hospital
Cincinnati, Ohio 45242
Cincinnati, Ohio 45242
The Cleveland Clinic Foundation
Cleveland, Ohio 44195
Cleveland, Ohio 44195
Hightower Clinical
Oklahoma City, Oklahoma 73102
Oklahoma City, Oklahoma 73102
Oklahoma Heart Institute at Utica
Tulsa, Oklahoma 74104
Tulsa, Oklahoma 74104
Pinnacle Health System
Harrisburg, Pennsylvania 17105
Harrisburg, Pennsylvania 17105
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania 15213
Pittsburgh, Pennsylvania 15213
WellSpan Health
York, Pennsylvania 17403
York, Pennsylvania 17403
Roper Hospital
Charleston, South Carolina 29401
Charleston, South Carolina 29401
Sanford USD Medical Center
Sioux Falls, South Dakota 57117
Sioux Falls, South Dakota 57117
Erlanger Medical Center
Chattanooga, Tennessee 37403
Chattanooga, Tennessee 37403
Tennova Healthcare-Turkey Creek Medical Center
Knoxville, Tennessee 37920
Knoxville, Tennessee 37920
Vanderbilt Heart & Vascular Institute
Nashville, Tennessee 37232
Nashville, Tennessee 37232
Texas Cardiac Arrhythmia
Austin, Texas 78705
Austin, Texas 78705
Baylor All Saints Medical Center at Fort Worth
Fort Worth, Texas 76104
Fort Worth, Texas 76104
Park Plaza Hospital
Houston, Texas 77004
Houston, Texas 77004
The Methodist Hospital
Houston, Texas 77030
Houston, Texas 77030
Memorial Katy Cardiology Associates
Houston, Texas 77094
Houston, Texas 77094
The Heart Hospital Baylor Plano
Plano, Texas 75093
Plano, Texas 75093
Methodist Texsan Hospital
San Antonio, Texas 78201
San Antonio, Texas 78201
Heart Rhythm Associates
Shenandoah, Texas 77380
Shenandoah, Texas 77380
Sentara Norfolk General Hospital
Norfolk, Virginia 23507
Norfolk, Virginia 23507
Monongalia General Hospital
Morgantown, West Virginia 26505
Morgantown, West Virginia 26505
More Details
- NCT ID
- NCT04226547
- Status
- Recruiting
- Sponsor
- Abbott Medical Devices