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AMPLATZER™ LAA Occluder Post Approval Study (PAS)

NCT02964208 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 520

Last updated 2024-03-29

Study results available
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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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Ryan Palmer · Abbott

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-08
Primary Completion
2022-06-13
Completion
2022-08-10
FDA Device
Yes

Countries

  • Argentina
  • Belgium
  • Canada
  • Chile
  • Germany
  • Italy
  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02964208 on ClinicalTrials.gov