AMPLATZER™ LAA Occluder Post Approval Study (PAS)

Browse trials for

• Atrial Fibrillation 3,872
• Thromboembolism 818

Keywords

• Atrial Fibrillation
• Stroke
• Left Atrial Appendage
• Cardiac Plug
• Amulet
• Thromboembolism

Atrial Fibrillation

3,872 studies on the registry are indexed under Atrial Fibrillation; 926 are open to participants now.

This study's enrollment of 520 is above the median of 300 across 1,364 observational studies indexed under Atrial Fibrillation.

Lead sponsor

Abbott Medical Devices is the lead sponsor of 525 studies on the registry; 35 are open to participants now.

Of its 52 completed or terminated interventional studies of FDA-regulated products, 43 (83%) have results posted.

Study population

Groups and cohorts

• LAA Occluder PAS

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

  Device: AMPLATZER™ LAA Occluder

Interventions

• DeviceAMPLATZER™ 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.

  Also known as: 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

   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

   Time frame: Implant through 24 months

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

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

   Time frame: Implant through 24 months

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

   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

   Time frame: Implant through 7 days

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

   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.

   Time frame: Implant through 24 months

Baseline characteristics

Study documents

• Study protocol · Nov 19, 2018
• Statistical analysis plan · Sep 9, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No