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AMPLATZER™ LAA Occluder Post Approval Study (PAS)

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ClinicalTrials.gov Identifier: NCT02964208
Recruitment Status : Active, not recruiting
First Posted : November 16, 2016
Last Update Posted : June 8, 2021
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Study Description
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Brief Summary:
The AMPLATZER LAA Occluder is a transcatheter, self-expanding nitinol device intended for use in preventing thrombus embolization from the LAA. The purpose of this study is to compile real world outcome data on the use of AMPLATZER LAA Occluder in subjects with non-valvular atrial fibrillation (NVAF)

Condition or disease Intervention/treatment
Atrial Fibrillation Thromboembolism Stroke Device: AMPLATZER™ LAA Occluder

Detailed Description:
The AMPLATZER LAA Occluder device will be clinically evaluated through this post approval study. This is a non-randomized multicenter study on patients who have undergone a procedure to implant an AMPLATZER LAA Occluder or will undergo an implant of an AMPLATZER LAA Occluder.
Study Design
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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: AMPLATZER™ LAA Occluder Post Approval Study (PAS)
Study Start Date : October 2016
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : October 2022

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Groups and Cohorts
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Intervention Details:
  • Device: AMPLATZER™ LAA Occluder
    The AMPLATZER™ LAA Occluder is intended to prevent thrombus embolization from the left atrial appendage (LAA) in patients who have nonvalvular Atrial Fibrillation (AF). It may be considered for use in patients who have a high risk of stroke and bleeding and are deemed by their physician to have an appropriate rationale to seek a non-pharmacologic alternative to long term anticoagulants.
    Other Names:
    • AMPLATZER™ Cardiac Plug™
    • AMPLATZER™ Amulet™

Outcome Measures
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Primary Outcome Measures :
  1. The occurrence of one or more adverse events listed in description below [ Time Frame: Implant through 24 months ]
    The occurrence of one or more the composite of stroke (including ischemic or hemorrhagic), systemic embolism, or cardiovascular or unexplained death at 24 months from the time of enrollment

  2. The occurrence of ischemic stroke or systemic embolism as listed in description below. [ Time Frame: Implant through 24 months ]
    The occurrence of ischemic stroke or systemic embolism at 24 months from the time of enrollment

  3. The occurrence of a major adverse event within 7 days [ Time Frame: Implant through 7 days ]
    The occurrence of one of the following events between the time of implant and within 7 days of the procedure or by hospital discharge, whichever is later: all-cause death, ischemic stroke, systemic embolism, or device or procedure-related events requiring open cardiac surgery or major endovascular repair


Secondary Outcome Measures :
  1. Comparison of the observed rate of ischemic stroke at 24months with the CHA2DS2-VASc predicted rate [ Time Frame: Implant through 24 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The subject population will include participants that are > 18 years old and diagnosed with NVAF.
Criteria

Inclusion Criteria:

  • 18 years of age or older
  • Documented history of nonvalvular atrial fibrillation
  • Subjects in whom an AMPLATZER LAA Occluder device is intended to be implanted or Subjects who underwent an AMPLATZER LAA Occluder implant attempt after the device was approved in the applicable geography

Exclusion Criteria:

  • Women of childbearing potential who are, or plan to become, pregnant during the time of the study
Contacts and Locations
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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): NCT02964208


Locations
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Sponsors and Collaborators
Abbott Medical Devices
Investigators
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Study Director: Maren Wagner Abbott
More Information
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Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT02964208    
Other Study ID Numbers: SJM-CIP-10122
First Posted: November 16, 2016    Key Record Dates
Last Update Posted: June 8, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Abbott Medical Devices:
Atrial Fibrillation
Thromboembolism
Stroke
ACP
 Left Atrial Appendage
Cardiac Plug
Amulet
Amplatzer
Additional relevant MeSH terms:
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Atrial Fibrillation
Thromboembolism
Vascular Diseases
Cardiovascular Diseases
 Arrhythmias, Cardiac
Heart Diseases
Pathologic Processes
Embolism and Thrombosis