AMPLATZER™ LAA Occluder Post Approval Study (PAS)

Abbott

Status: Completed

Conditions: Thromboembolism; Atrial Fibrillation; Stroke

Treatments: Device: AMPLATZER™ LAA Occluder

Study type: Observational

Funder types: Industry

Identifiers

NCT02964208

SJM-CIP-10122

Details and patient eligibility

About

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.

Enrollment: 520 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

520 participants in 1 patient group

LAA Occluder PAS

Description:

Subjects who were treated with AMPLATZER LAA Occluders will be included.

Treatment:

Device: AMPLATZER™ LAA Occluder