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Amplatzer Amulet LAAO vs. NOAC (CATALYST)

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ClinicalTrials.gov Identifier: NCT04226547
Recruitment Status : Recruiting
First Posted : January 13, 2020
Last Update Posted : June 7, 2021
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Tracking Information
First Submitted Date  ICMJE January 9, 2020
First Posted Date  ICMJE January 13, 2020
Last Update Posted Date June 7, 2021
Actual Study Start Date  ICMJE July 7, 2020
Estimated Primary Completion Date December 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 3, 2020)
  • Composite of ischemic stroke, systemic embolism, or cardiovascular (CV) mortality [ Time Frame: 2 years ]
    non-inferiority
  • Major bleeding or clinically relevant non-major bleeding (CRNMB) events, excluding procedure related events [ Time Frame: 2 years ]
    superiority
  • Composite of ischemic stroke or systemic embolism [ Time Frame: 3 years ]
    non-inferiority
Original Primary Outcome Measures  ICMJE
 (submitted: January 10, 2020)
  • Primary Endpoint #1 (Composite event) [ Time Frame: 2 years ]
    Composite of ischemic stroke, systemic embolism, or cardiovascular (CV) mortality (non-inferiority)
  • Primary Endpoint #2A (bleeding) [ Time Frame: 2 years ]
    Major bleeding or clinically relevant non-major bleeding (CRNMB) events (non-inferiority)
  • Primary Endpoint #2B (bleeding or CRNMB events) [ Time Frame: 2 years ]
    Major bleeding or CRNMB events, excluding procedure related events (superiority)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 3, 2020)
  • Major bleeding or CRNMB events [ Time Frame: 2 years ]
    non-inferiority
  • Major bleeding or CRNMB events [ Time Frame: 2 years ]
    superiority
  • Disabling or fatal strokes [ Time Frame: 2 years ]
    superiority
Original Secondary Outcome Measures  ICMJE
 (submitted: January 10, 2020)
  • Secondary Endpoint #1 (composite event) [ Time Frame: 2 years ]
    Composite of ischemic stroke or systemic embolism (non-inferiority)
  • Secondary Endpoint #2 (device or procedure related complication) [ Time Frame: 7 days ]
    Serious device- or procedure-related complication post-index procedure for Device Group subjects
  • Secondary Endpoint #3 (bleeding or CRNMB events) [ Time Frame: 2 years ]
    Major bleeding or CRNMB events (superiority)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Amplatzer Amulet LAAO vs. NOAC
Official Title  ICMJE Clinical Trial of Atrial Fibrillation Patients Comparing Left Atrial Appendage Occlusion Therapy to Non-vitamin K Antagonist Oral Anticoagulants
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Atrial Fibrillation
  • Stroke
  • Bleeding
Intervention  ICMJE
  • Device: Left Atrial Appendage Occlusion (Amplatzer Amulet LAA Occluder)
    Implantation of an Amplatzer Amulet left atrial appendage occluder
    Other Name: Amplatzer Amulet LAA Occluder
  • Drug: Non-Vitamin K Oral Antagonists
    Initiation or continuation of a NOAC drug
    Other Name: NOAC
Study Arms  ICMJE
  • Experimental: Device Group
    Randomized to Amplatzer Amulet LAA occluder
    Intervention: Device: Left Atrial Appendage Occlusion (Amplatzer Amulet LAA Occluder)
  • Active Comparator: Control Group
    Randomized to NOAC
    Intervention: Drug: Non-Vitamin K Oral Antagonists
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 10, 2020)
2650
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2029
Estimated Primary Completion Date December 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: CATALYST Study Team (408) 845-0536 catalyststudy@abbott.com
Listed Location Countries  ICMJE Australia,   Canada,   Czechia,   Denmark,   France,   Germany,   Hong Kong,   Italy,   Poland,   Spain,   Switzerland,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04226547
Other Study ID Numbers  ICMJE 10310
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Abbott Medical Devices
Study Sponsor  ICMJE Abbott Medical Devices
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Vivek Reddy, MD Mt. Sinai Medical Center
PRS Account Abbott Medical Devices
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP