N/A
N=520
AMPLATZER™ LAA Occluder Post Approval Study (PAS)
Atrial Fibrillation · Thromboembolism · Stroke
Bottom Line
View on ClinicalTrials.gov: NCT02964208 ↗Enrolled (actual)
520
Serious AEs
38.7%
Results posted
Mar 2024
Primary outcome: Primary: Primary Effectiveness Endpoint 1: Composite Rate of Stroke (Including Ischemic or Hemorrhagic), Systemic Embolism and Cardiovascular or Unexplained Death — 14.28 percentage of participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- AMPLATZER™ LAA Occluder (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Abbott Medical Devices
- Primary completion
- Jun 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Effectiveness Endpoint 1: Composite Rate of Stroke (Including Ischemic or Hemorrhagic), Systemic Embolism and Cardiovascular or Unexplained Death |
14.28 | — |
| PRIMARY Primary Effectiveness Endpoint 2: Composite Rate of Ischemic Stroke or Systemic Embolism |
4.41 | — |
| PRIMARY Primary Safety Endpoint: Number of Subjects With All Cause Death, Ischemic Stroke, Systemic Embolism, or Device or Procedure-Related Events Requiring Open Cardiac Surgery or Major Endovascular Repair |
3 | — |
| SECONDARY Comparison of the Relative Risk Decrease Of Observed Rate of Ischemic Stroke at 24 Months With the CHA2DS2-VASc Predicted Rate for the Implant Population |
-70 | — |
Summary
The aim of this multicenter, non-randomized observational post-approval is to compile real world outcome data on the use of an AMPLATZER LAA Occluder in subjects with non-valvular atrial fibrillation (NVAF). The AMPLATZER LAA Occluders is a transcatheter, self-expanding nitinol device intended for use in preventing thrombus embolization from the LAA.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02964208). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.