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Amplatzer Amulet LAAO vs. NOAC (CATALYST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04226547
Recruitment Status : Recruiting
First Posted : January 13, 2020
Last Update Posted : August 5, 2020
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

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
Atrial Fibrillation Stroke Bleeding Device: Left Atrial Appendage Occlusion (Amplatzer Amulet LAA Occluder) Drug: Non-Vitamin K Oral Antagonists Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : July 7, 2020
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : April 2029

Resource links provided by the National Library of Medicine


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 Name: 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 Name: NOAC




Primary Outcome Measures :
  1. Composite of ischemic stroke, systemic embolism, or cardiovascular (CV) mortality [ Time Frame: 2 years ]
    non-inferiority

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

  3. Composite of ischemic stroke or systemic embolism [ Time Frame: 3 years ]
    non-inferiority


Secondary Outcome Measures :
  1. Major bleeding or CRNMB events [ Time Frame: 2 years ]
    non-inferiority

  2. Major bleeding or CRNMB events [ Time Frame: 2 years ]
    superiority

  3. Disabling or fatal strokes [ Time Frame: 2 years ]
    superiority



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04226547


Contacts
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Contact: CATALYST Study Team (408) 845-0536 catalyststudy@abbott.com

Locations
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Czechia
Fakultni nemocnice Kralovske Vinohrady Recruiting
Prague, Czechia
Nemocnice Na Homolce Recruiting
Prague, Czechia
Sponsors and Collaborators
Abbott Medical Devices
Investigators
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Principal Investigator: Vivek Reddy, MD Mt. Sinai Medical Center
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Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT04226547    
Other Study ID Numbers: 10310
First Posted: January 13, 2020    Key Record Dates
Last Update Posted: August 5, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes