Completed

AMPLATZER™ LAA Occluder Post Approval Study

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What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Arrhythmias, Cardiac+11

+ Atrial Fibrillation

+ Brain Diseases

Over 18 Years
+4 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: December 2016
See protocol details

Summary

Principal SponsorAbbott Medical Devices
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: December 8, 2016

Actual date on which the first participant was enrolled.

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.

Official TitleAMPLATZER™ LAA Occluder Post Approval Study
NCT02964208
Principal SponsorAbbott Medical Devices
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

520 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Arrhythmias, CardiacAtrial FibrillationBrain DiseasesCardiovascular DiseasesCentral Nervous System DiseasesCerebrovascular DisordersHeart DiseasesNervous System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsThromboembolismVascular DiseasesEmbolism and ThrombosisStroke

Criteria

3 inclusion criteria required to participate
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
1 exclusion criteria prevent from participating
Women of childbearing potential who are, or plan to become, pregnant during the time of the study

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 22 locations

Suspended

Instituto Cardiovascular de Rosario

Rosario, ArgentinaOpen Instituto Cardiovascular de Rosario in Google Maps
Suspended

Hôpital Civil Marie Curie

Lodelinsart, Belgium
Suspended

Royal Columbian

New Westminster, Canada
Suspended

Vancouver General Hospital

Vancouver, Canada
Completed22 Study Centers