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CATALYST: Amplatzer Amulet LAAO vs. NOAC

Sponsor
Abbott Medical Devices (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04226547
Collaborator
(none)
2,650
Enrollment
103
Locations
2
Arms
104.8
Anticipated Duration (Months)
25.7
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Left Atrial Appendage Occlusion (Amplatzer Amulet LAA Occluder)
  • Drug: Non-Vitamin K Oral Antagonists
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
2650 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Clinical Trial of Atrial Fibrillation Patients Comparing Left Atrial Appendage Occlusion Therapy to Non-vitamin K Antagonist Oral Anticoagulants
Actual Study Start Date :
Jul 7, 2020
Anticipated Primary Completion Date :
Dec 1, 2024
Anticipated Study Completion Date :
Apr 1, 2029

Arms and Interventions

Arm Intervention/Treatment
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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Composite of ischemic stroke, systemic embolism, or cardiovascular (CV) mortality [2 years]

      non-inferiority

    2. Major bleeding or clinically relevant non-major bleeding (CRNMB) events, excluding procedure related events [2 years]

      superiority

    3. Composite of ischemic stroke or systemic embolism [3 years]

      non-inferiority

    Secondary Outcome Measures

    1. Major bleeding or CRNMB events [2 years]

      non-inferiority

    2. Major bleeding or CRNMB events [2 years]

      superiority

    3. Disabling or fatal strokes [2 years]

      superiority

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Hospital - Univ. of Alabama at Birmingham (UAB) Birmingham Alabama United States 35249
    2 Heart Center Research, LLC Huntsville Alabama United States 35801
    3 Arizona Cardiovascular Research Center Phoenix Arizona United States 85016
    4 Arrhythmia Research Group Jonesboro Arkansas United States 72401
    5 UAMS Medical Center Little Rock Arkansas United States 72205
    6 Scripps Health La Jolla California United States 92037
    7 Kaiser Permanente Los Angeles Medical Center Los Angeles California United States 90027
    8 Huntington Memorial Hospital Pasadena California United States 91109
    9 Mercy Medical Group - Cardiology Sacramento California United States 95819
    10 South Denver Cardiology Associates PC Littleton Colorado United States 80120
    11 MedStar Washington Hospital Center Washington District of Columbia United States 20010
    12 Baptist Medical Center Jacksonville Florida United States 32207
    13 NCH Healthcare System Naples Florida United States 34102
    14 AdventHealth Orlando Orlando Florida United States 32803
    15 Sarasota Memorial Hospital Sarasota Florida United States 34239
    16 Piedmont Heart Institute Atlanta Georgia United States 30309
    17 Emory University Hospital Atlanta Georgia United States 30322
    18 Northside Hospital Atlanta Georgia United States 30342
    19 Northwestern Memorial Hospital Chicago Illinois United States 60611
    20 Lutheran Hospital of Indiana Fort Wayne Indiana United States 46801
    21 St. Vincent Hospital Indianapolis Indiana United States 46240
    22 Kansas University Medical Center Kansas City Kansas United States 66160
    23 Kansas City Cardiac Arrhythmia Research Foundation Overland Park Kansas United States 66211
    24 Cardiovascular Research Institute of Kansas Wichita Kansas United States 67226
    25 Baptist Health Lexington Lexington Kentucky United States 40503
    26 Louisiana Cardiology Associates Baton Rouge Louisiana United States 70808
    27 Cardiovascular Institute of the South Houma Louisiana United States 70361
    28 Tufts Medical Center Boston Massachusetts United States 02111
    29 Beth Israel Deaconess Medical Center Boston Massachusetts United States 02215
    30 Spectrum Health Butterworth Hospital Grand Rapids Michigan United States 49503
    31 VA Medical Center Minneapolis Minneapolis Minnesota United States 55417
    32 St. Cloud Hospital - Central MN Heart Clinic Saint Cloud Minnesota United States 56303
    33 Jackson Heart Clinic Jackson Mississippi United States 39216
    34 CHI Health Creighton University Medical Center-Bergan Mercy Omaha Nebraska United States 68124
    35 Cooper University Hospital Camden New Jersey United States 08103
    36 New Mexico Heart Institute Albuquerque New Mexico United States 87102
    37 Buffalo General Hospital Buffalo New York United States 14203
    38 Mount Sinai Hospital New York New York United States 10019
    39 New York Presbyterian Hospital/Cornell University New York New York United States 10021
    40 Mission Health & Hospitals Asheville North Carolina United States 28801
    41 NC Heart & Vascular Research Raleigh North Carolina United States 27607
    42 TriHealth Bethesda North Hospital Cincinnati Ohio United States 45242
    43 The Cleveland Clinic Foundation Cleveland Ohio United States 44195
    44 Hightower Clinical Oklahoma City Oklahoma United States 73102
    45 Integris Baptist Medical Center Oklahoma City Oklahoma United States 73112
    46 Oklahoma Heart Institute at Utica Tulsa Oklahoma United States 74104
    47 Pinnacle Health System Harrisburg Pennsylvania United States 17105
    48 University of Pittsburgh Medical Center Pittsburgh Pennsylvania United States 15213
    49 WellSpan Health York Pennsylvania United States 17403
    50 Roper Hospital Charleston South Carolina United States 29401
    51 Sanford USD Medical Center Sioux Falls South Dakota United States 57117
    52 Tennova Healthcare-Turkey Creek Medical Center Knoxville Tennessee United States 37920
    53 Vanderbilt Heart & Vascular Institute Nashville Tennessee United States 37232
    54 Texas Cardiac Arrhythmia Austin Texas United States 78705
    55 Baylor All Saints Medical Center at Fort Worth Fort Worth Texas United States 76104
    56 Park Plaza Hospital Houston Texas United States 77004
    57 CHI St. Luke's Health Baylor College of Medicine Med. Ctr. Houston Texas United States 77030
    58 Memorial Hermann Hospital Houston Texas United States 77030
    59 The Methodist Hospital Houston Texas United States 77030
    60 Memorial Katy Cardiology Associates Houston Texas United States 77094
    61 The Heart Hospital Baylor Plano Plano Texas United States 75093
    62 South Texas Cardiovascular Consultants San Antonio Texas United States 78201
    63 Medical College of Wisconsin Milwaukee Wisconsin United States 53226
    64 Royal Adelaide Hospital Adelaide Australia 5000
    65 Fiona Stanley Hospital Murdoch Australia 6150
    66 Royal Melbourne Hospital - City Campus Parkville Australia 3050
    67 Ottawa Heart Institute Ottawa Ontario Canada K1Y 4W7
    68 Institut de Cardiologie de Montreal (Montreal Heart Inst.) Montréal Canada H1T 1C8
    69 CHUM Montréal Canada H2X 3E4
    70 Vancouver General Hospital (U of BC) Vancouver Canada V5Z 1M9
    71 Fakultni nemocnice Kralovske Vinohrady Prague Czechia 100 34
    72 Nemocnice Na Homolce Prague Czechia 150 30
    73 Skejby University Hospital Arhus Denmark 8200
    74 Rigshospitalet Copenhagen Denmark 2100
    75 CHU Gabriel Montpied Clermont-Ferrand France 63003
    76 Hopital Henri Mondor Créteil France 94010
    77 Institute Cardio. Paris-Sud - Institut Jacques Cartier Massy France 91300
    78 Mutualiste Montsouris Paris France 75014
    79 Hopital Haut Leveque Pessac France 33604
    80 Segeberger Kliniken GmbH Bad Segeberg Germany 23795
    81 St. Marien-Hospital-Bonn Bonn Germany 53115
    82 Cardioangiologisches Centrum am Bethanien Krankenhaus Frankfurt Germany 60389
    83 Klinikum der Justus-Liebig-Universität Gießen Germany 35392
    84 Universitätsmedizin der Johannes Gutenberg-Universität Mainz Mainz Germany 55131
    85 Internistisches Klinikum München SUD Munich Germany 81379
    86 Helios Klinikum Siegburg Siegburg Germany 53721
    87 Prince of Wales Hospital Hong Kong Hong Kong 999077
    88 The University of Hong Kong (Queen Mary Hospital) Hong Kong Hong Kong
    89 Fondazione Toscana Gabriele Monasterio Massa Italy 54100
    90 Ospedale San Raffaele Milano Italy 20132
    91 Kokura Memorial Hospital Kitakyushu Fukuoka Japan 802-8555
    92 Shonan Kamakura General Hospital Kamakura Kanagawa Japan 247-8533
    93 Sendai Kousei Hospital Sendai Miyagi Japan 980-0973
    94 St. Antonius Ziekenhuis Nieuwegein Netherlands 3435 CM
    95 Slaskie Centrum Chorob Serca Zabrze Poland 41-800
    96 Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi Łódź Poland 92-213
    97 Hospital Clinico San Carlos Madrid Community Of Madrid Spain
    98 Hospital de la Santa Creu I Sant Pau Barcelona Spain 08025
    99 Hospital Clinic I Provincial de Barcelona Barcelona Spain 08036
    100 Hospital Universitario de Salamanca Salamanca Spain 37007
    101 Center Inselspital Bern Bern Switzerland 3010
    102 Stadtspital Triemli Zürich Switzerland 8063
    103 The Royal Sussex County Hospital Brighton United Kingdom BN25BE

    Sponsors and Collaborators

    • Abbott Medical Devices

    Investigators

    • Principal Investigator: Vivek Reddy, MD, Mt. Sinai Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Abbott Medical Devices
    ClinicalTrials.gov Identifier:
    NCT04226547
    Other Study ID Numbers:
    • 10310
    First Posted:
    Jan 13, 2020
    Last Update Posted:
    Jul 12, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Additional relevant MeSH terms:
    Atrial Fibrillation

    Study Results

    No Results Posted as of Jul 12, 2022