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 : August 2, 2022
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Condition or disease | Intervention/treatment |
---|---|
Atrial Fibrillation Thromboembolism Stroke | Device: AMPLATZER™ LAA Occluder |
Study Type : | Observational |
Estimated Enrollment : | 1000 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | AMPLATZER™ LAA Occluder Post Approval Study (PAS) |
Actual Study Start Date : | December 9, 2016 |
Actual Primary Completion Date : | June 30, 2020 |
Estimated Study Completion Date : | June 30, 2023 |

- 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™
- 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
- 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
- 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
- Comparison of the observed rate of ischemic stroke at 24months with the CHA2DS2-VASc predicted rate [ Time Frame: Implant through 24 months ]

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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 |
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

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

Study Director: | Maren Wagner | Abbott |
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: | August 2, 2022 |
Last Verified: | August 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Atrial Fibrillation Thromboembolism Stroke ACP |
Left Atrial Appendage Cardiac Plug Amulet Amplatzer |
Atrial Fibrillation Thromboembolism Vascular Diseases Cardiovascular Diseases |
Arrhythmias, Cardiac Heart Diseases Pathologic Processes Embolism and Thrombosis |