AMPLATZER™ LAA Occluder Post Approval Study (PAS)
- Conditions
- Atrial FibrillationThromboembolismStroke
- Registration Number
- NCT02964208
- Lead Sponsor
- Abbott Medical Devices
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 520
- 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
- Women of childbearing potential who are, or plan to become, pregnant during the time of the study
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 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
Primary Effectiveness Endpoint 2: Composite Rate of Ischemic Stroke or Systemic Embolism Implant through 24 months The occurrence of ischemic stroke or systemic embolism at 24 months from the time of enrollment
Primary Effectiveness Endpoint 1: Composite Rate of Stroke (Including Ischemic or Hemorrhagic), Systemic Embolism and Cardiovascular or Unexplained Death 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
- Secondary Outcome Measures
Name Time Method 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 Implant through 24 months The secondary endpoint comparing the observed rate of ischemic stroke at 24 months with the congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, stroke or transient ischemic attack (TIA), vascular disease, age 65 to 74 years, sex category (CHA2DS2-VASc) score predicted rate for the implant population. The following calculation was used to calculate the Relative Risk Decrease: (Predicted Rate minus Observed Rate) divided by Predicted Rate = Relative Risk Decrease.
Trial Locations
- Locations (22)
Instituto Cardiovascular de Rosario
🇦🇷Rosario, Santa Fe, Argentina
Hôpital Civil Marie Curie
🇧🇪Lodelinsart, Hainaut, Belgium
Royal Columbian
🇨🇦New Westminster, British Columbia, Canada
Vancouver General Hospital
🇨🇦Vancouver, British Columbia, Canada
St. Paul's Hospital
🇨🇦Vancouver, British Columbia, Canada
Ottawa Heart Institute
🇨🇦Ottawa, Ontario, Canada
St. Michael's Hospital
🇨🇦Toronto, Ontario, Canada
Montreal Heart Institute
🇨🇦Montreal, Quebec, Canada
CHUM
🇨🇦Montreal, Quebec, Canada
The Royal Victoria Hospital
🇨🇦Montréal, Quebec, Canada
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