CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 520 enrolled
Drug / intervention
AMPLATZER™ LAA Occluderdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02964208
NCT02964208N/ACompleted
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AMPLATZER™ LAA Occluder Post Approval Study

Abbott Medical Devices·observational·Posted Nov 16, 2016·Updated Mar 29, 2024

In Brief

An observational study evaluating AMPLATZER™ LAA Occluder for Atrial Fibrillation and 2 related conditions. Completed, enrolled 520 participants across 22 sites in 7 countries.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsAtrial Fibrillation, Thromboembolism, Stroke
CountriesArgentina, Belgium, Canada, Chile, Germany, Italy, Spain
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedNov 16, 2016
Enrollment StartDec 8, 2016
Primary CompletionJun 13, 2022
Study CompletionAug 10, 2022
TodayJul 2, 2026
Enrollment to primary: 5.5 yearsPosted 9.6 years ago

Interventions

AMPLATZER™ LAA Occluderdevice

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.