RECRUITING

Amplatzer Amulet LAAO vs. NOAC

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Conditions

Atrial FibrillationStrokeBleeding

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Clinical Trial of Atrial Fibrillation Patients Comparing Left Atrial Appendage Occlusion Therapy to Non-vitamin K Antagonist Oral Anticoagulants

Quick Facts

Study Start:2020-07-07
Study Completion:2030-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04226547

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Documented paroxysmal, persistent, or permanent non-valvular AF (documentation must include an electrocardiogram, Holter, or event recorder)
  2. * At high risk of stroke or systemic embolism, defined as a CHA2DS2-VASc score of ≥ 2 for men and ≥ 3 for women
  3. * Eligible for long-term NOAC therapy
  4. * Able to comply with the required NOAC medication regimen if randomized to the Control Group
  5. * 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
  6. * 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
  7. * 18 years of age or older, or the age of legal consent
  8. * Able and willing to return for required follow-up visits and assessments
  1. * Requires long-term OAC therapy for a condition other than AF
  2. * 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)
  3. * Known contraindication to, or allergic to, aspirin, clopidogrel, or OAC medication use
  4. * Indicated for P2Y12 platelet inhibitor for \>1 year post-randomization
  5. * In the opinion of the investigator, is considered at high risk for general anesthesia and general anesthesia is planned for the study procedure
  6. * Has undergone atrial septal defect (ASD) repair or has an ASD closure device present
  7. * Has undergone patent foramen ovale (PFO) repair or has a PFO closure device implanted
  8. * Is implanted with a mechanical valve prosthesis
  9. * Is implanted with an inferior vena cava filter
  10. * History of rheumatic or congenital mitral valve heart disease
  11. * 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)
  12. * Customary contraindications for TEE/TOE (e.g., presence of esophageal varices, esophageal stricture, or history of esophageal cancer)
  13. * Experienced stroke or transient ischemic attack (TIA) within 90 days prior to randomization or implant procedure (as applicable)
  14. * Underwent any cardiac or non-cardiac intervention or surgery within 30 days prior to randomization
  15. * Underwent catheter ablation for AF or atrial flutter within 60 days prior to randomization
  16. * Experienced myocardial infarction within 90 days prior to randomization
  17. * New York Heart Association Class IV Congestive Heart Failure
  18. * Left ventricular ejection fraction ≤ 30% (per most recent assessment)
  19. * 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
  20. * Has known intracranial atherosclerosis and/or intracranial small vessel disease (defined as 6 points on the Fazekas Scale)
  21. * Reversible cause of AF (i.e., secondary to thyroid disorders, acute alcohol intoxication, trauma, recent major surgical procedures)
  22. * History of idiopathic or recurrent venous thromboembolism
  23. * LAA is obliterated or surgically ligated
  24. * Thrombocytopenia (defined as \< 50,000 platelets per microliter (\<50 x 10\^9 /L)or anemia (defined as hemoglobin \< 10 g/dL) requiring transfusions
  25. * Hypersensitivity to any portion of the device material or individual components of the Amulet LAA occluder device (e.g., nickel allergy)
  26. * 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
  27. * Is pregnant or breastfeeding, or pregnancy is planned during the course of the investigation
  28. * Active endocarditis or other infection producing bacteremia
  29. * Transient case of AF (i.e., never previously detected, provoked/induced by surgical or catheter manipulations, etc.)
  30. * Severe renal failure (estimated glomerular filtration rate \<30 ml/min/1.73m2), but not on dialysis
  31. * Life expectancy is less than 2 years in the opinion of the Investigator
  32. * 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.

Contacts and Locations

Study Contact

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

Principal Investigator

Vivek Reddy, MD
PRINCIPAL_INVESTIGATOR
Mt. Sinai Medical Center

Study Locations (Sites)

University Hospital - Univ. of Alabama at Birmingham (UAB)
Birmingham, Alabama, 35249
United States
Heart Center Research, LLC
Huntsville, Alabama, 35801
United States
Arizona Cardiovascular Research Center
Phoenix, Arizona, 85016
United States
Tucson Medical Center
Tucson, Arizona, 85712
United States
Arrhythmia Research Group
Jonesboro, Arkansas, 72401
United States
UAMS Medical Center
Little Rock, Arkansas, 72205
United States
Scripps Health
La Jolla, California, 92037
United States
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, 90027
United States
Huntington Memorial Hospital
Pasadena, California, 91109
United States
Mercy Medical Group - Cardiology
Sacramento, California, 95819
United States
University of California at San Diego (UCSD) Medical Center
San Diego, California, 92103
United States
South Denver Cardiology Associates PC
Littleton, Colorado, 80120
United States
MedStar Washington Hospital Center
Washington, District of Columbia, 20010
United States
AdventHealth Florida Cardiology - Altamonte Springs
Altamonte Springs, Florida, 32701
United States
St. Vincent's Medical Center
Jacksonville, Florida, 32204
United States
Baptist Medical Center
Jacksonville, Florida, 32207
United States
AdventHealth Florida Cardiology - Lake Mary
Lake Mary, Florida, 32746
United States
NCH Healthcare System
Naples, Florida, 34102
United States
AdventHealth Orlando
Orlando, Florida, 32803
United States
AdventHealth Florida Cardiology - Oviedo
Oviedo, Florida, 32765
United States
Sarasota Memorial Hospital
Sarasota, Florida, 34239
United States
Piedmont Heart Institute
Atlanta, Georgia, 30309
United States
Emory University Hospital
Atlanta, Georgia, 30322
United States
Northside Hospital
Atlanta, Georgia, 30342
United States
St. Joseph's Hospital
Atlanta, Georgia, 30342
United States
Northside Hospital (CardioVascular Group Lawrenceville)
Lawrenceville, Georgia, 30045
United States
Northwestern Memorial Hospital
Chicago, Illinois, 60611
United States
Rush University Medical Center
Chicago, Illinois, 60612
United States
Central DuPage Hospital
Winfield, Illinois, 60190
United States
Lutheran Hospital of Indiana
Fort Wayne, Indiana, 46801
United States
St. Vincent Hospital
Indianapolis, Indiana, 46240
United States
Kansas University Medical Center
Kansas City, Kansas, 66160
United States
Kansas City Cardiac Arrhythmia Research Foundation
Overland Park, Kansas, 66211
United States
Overland Park Mid America Cardiology
Overland Park, Kansas, 66211
United States
Cardiovascular Research Institute of Kansas
Wichita, Kansas, 67226
United States
Baptist Health Lexington
Lexington, Kentucky, 40503
United States
Louisiana Cardiology Associates
Baton Rouge, Louisiana, 70808
United States
Cardiovascular Institute of the South
Houma, Louisiana, 70361
United States
MedStar Union Memorial Hospital
Baltimore, Maryland, 21218
United States
Tufts Medical Center
Boston, Massachusetts, 02111
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
United States
Spectrum Health Butterworth Hospital
Grand Rapids, Michigan, 49503
United States
VA Medical Center Minneapolis
Minneapolis, Minnesota, 55417
United States
St. Cloud Hospital - Central MN Heart Clinic
Saint Cloud, Minnesota, 56303
United States
Jackson Heart Clinic
Jackson, Mississippi, 39216
United States
Bryan Heart
Lincoln, Nebraska, 68506
United States
CHI Health Creighton University Medical Center-Bergan Mercy
Omaha, Nebraska, 68124
United States
Cooper University Hospital
Camden, New Jersey, 08103
United States
New Mexico Heart Institute
Albuquerque, New Mexico, 87102
United States
South Shore University Hospital-Northwell
Bay Shore, New York, 11706
United States
Buffalo General Hospital
Buffalo, New York, 14203
United States
Mount Sinai Hospital
New York, New York, 10019
United States
New York Presbyterian Hospital/Cornell University
New York, New York, 10021
United States
Staten Island University Hospital Northwell
Staten Island, New York, 10305
United States
Mission Health & Hospitals
Asheville, North Carolina, 28801
United States
NC Heart & Vascular Research
Raleigh, North Carolina, 27607
United States
TriHealth Bethesda North Hospital
Cincinnati, Ohio, 45242
United States
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
United States
Hightower Clinical
Oklahoma City, Oklahoma, 73102
United States
Integris Baptist Medical Center
Oklahoma City, Oklahoma, 73112
United States
Oklahoma Heart Institute at Utica
Tulsa, Oklahoma, 74104
United States
Pinnacle Health System
Harrisburg, Pennsylvania, 17105
United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
United States
WellSpan Health
York, Pennsylvania, 17403
United States
Roper Hospital
Charleston, South Carolina, 29401
United States
Sanford USD Medical Center
Sioux Falls, South Dakota, 57117
United States
Erlanger Medical Center
Chattanooga, Tennessee, 37403
United States
Tennova Healthcare-Turkey Creek Medical Center
Knoxville, Tennessee, 37920
United States
Vanderbilt Heart & Vascular Institute
Nashville, Tennessee, 37232
United States
Texas Cardiac Arrhythmia
Austin, Texas, 78705
United States
Baylor All Saints Medical Center at Fort Worth
Fort Worth, Texas, 76104
United States
Park Plaza Hospital
Houston, Texas, 77004
United States
CHI St. Luke's Health Baylor College of Medicine Med. Ctr.
Houston, Texas, 77030
United States
Memorial Hermann Hospital
Houston, Texas, 77030
United States
The Methodist Hospital
Houston, Texas, 77030
United States
Memorial Katy Cardiology Associates
Houston, Texas, 77094
United States
The Heart Hospital Baylor Plano
Plano, Texas, 75093
United States
Methodist Texsan Hospital
San Antonio, Texas, 78201
United States
Heart Rhythm Associates
Shenandoah, Texas, 77380
United States
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507
United States
Monongalia General Hospital
Morgantown, West Virginia, 26505
United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: Abbott Medical Devices

  • Vivek Reddy, MD, PRINCIPAL_INVESTIGATOR, Mt. Sinai Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-07-07
Study Completion Date2030-08

Study Record Updates

Study Start Date2020-07-07
Study Completion Date2030-08

Terms related to this study

Additional Relevant MeSH Terms

  • Atrial Fibrillation
  • Stroke
  • Bleeding