Skip to main content
OpenTrials
Completed

NCT Number: NCT02964208

AMPLATZER™ LAA Occluder Post Approval Study (PAS)

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Embolism and Thrombosis Heart Diseases Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Thromboembolism Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Instituto Cardiovascular de Rosario, Rosario, Santa Fe Province, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AMPLATZER™ LAA Occluder

Device

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.

Other names: AMPLATZER™ Cardiac Plug™, AMPLATZER™ Amulet™

Primary outcomes

  1. Primary Effectiveness Endpoint 1: Composite Rate of Stroke (Including Ischemic or Hemorrhagic), Systemic Embolism and Cardiovascular or Unexplained Death

    Time frame: 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

  2. Primary Effectiveness Endpoint 2: Composite Rate of Ischemic Stroke or Systemic Embolism

    Time frame: Implant through 24 months

    The occurrence of ischemic stroke or systemic embolism at 24 months from the time of enrollment

  3. 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

    Time frame: 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

Secondary outcomes

  1. 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Official study title

AMPLATZER™ LAA Occluder Post Approval Study

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
Nov 16, 2016
Registry last updated
Mar 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.