AMPLATZER™ LAA Occluder Post Approval Study (PAS)

AMPLATZER™ LAA Occluder Post Approval Study

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Atrial Fibrillation; Thromboembolism
• Intervention / Treatment: Device: AMPLATZER™ LAA Occluder

Detailed Description

The AMPLATZER LAA Occluder device will be clinically evaluated through this post approval study. This is a non-randomized multicenter study on patients who have undergone a procedure to implant an AMPLATZER LAA Occluder or will undergo an implant of an AMPLATZER LAA Occluder.

• Study Type: Observational
• Enrollment (Actual): 520

Contacts and Locations

Study Locations

• Argentina
  • Santa Fe
    • Rosario, Santa Fe, Argentina, 2000
      • Instituto Cardiovascular de Rosario
• Belgium
  • Hainaut
    • Lodelinsart, Hainaut, Belgium, 6042
      • Hôpital Civil Marie Curie
• Canada
  • British Columbia
    • New Westminster, British Columbia, Canada, V3L 3W5
      • Royal Columbian
    • Vancouver, British Columbia, Canada, V5Z 1M9
      • Vancouver General Hospital
    • Vancouver, British Columbia, Canada, V6Z 2E8
      • St. Paul's Hospital
  • Ontario
    • Ottawa, Ontario, Canada, K1Y 4W7
      • Ottawa Heart Institute
    • Toronto, Ontario, Canada, M5B 1W8
      • St. Michael's Hospital
  • Quebec
    • Montreal, Quebec, Canada, H2L 4M1
      • Montreal Heart Institute
    • Montreal, Quebec, Canada, H2X 3E4
      • CHUM
    • Montréal, Quebec, Canada, H4A 3J1
      • The Royal Victoria Hospital
• Chile
  • Santiago, Chile, 8320000
    • Hospital Clinico San Borja Arriaran
  • Santiago
    • Providencia, Santiago, Chile
      • Instituto Nacional del Tórax
• Germany
  • Hesse
    • Frankfurt, Hesse, Germany, 60389
      • Cardioangiologisches Centrum am Bethanien Krankenhaus
  • North Rhine-Westphalia
    • Bonn, North Rhine-Westphalia, Germany, 53115
      • St. Marien-Hospital-Bonn
  • Schleswig-Holstein
    • Bad Segeberg, Schleswig-Holstein, Germany, 23795
      • Segeberger Kliniken GmbH
  • Thuringia
    • Bad Berka, Thuringia, Germany, 99438
      • Zentralklinik Bad Berka GmbH
• Italy
  • Campania
    • Napoli, Campania, Italy, 80131
      • Azienda Ospedaliera Monaldi
  • Piedmonte
    • Torino, Piedmonte, Italy, 10154
      • Ospedale San Giovanni Bosco
  • Veneto
    • Padova, Veneto, Italy, 35128
      • Universita Degli Studi Di Padova
• Spain
  • Castile And Leon
    • Salamanca, Castile And Leon, Spain, 37007
      • Hospital Universitario de Salamanca
  • Catalonia
    • Barcelona, Catalonia, Spain, 8028
      • Hospital Clinic i Provincial de Barcelona
  • Madrid
    • Majadahonda, Madrid, Spain, 28222
      • Hospital Universitario Puerta de Hierro

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The subject population will include participants that are > 18 years old and diagnosed with NVAF.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

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.; Other Names: AMPLATZER™ Cardiac Plug™; AMPLATZER™ Amulet™

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Implant through 24 months
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	Implant through 24 months
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	Implant through 7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Implant through 24 months

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Study Director: Ryan Palmer, Abbott

Study record dates

Study Major Dates

• Study Start (Actual): December 8, 2016
• Primary Completion (Actual): June 13, 2022
• Study Completion (Actual): August 10, 2022

Study Registration Dates

• First Submitted: October 6, 2016
• First Submitted That Met QC Criteria: November 10, 2016
• First Posted (Estimated): November 16, 2016

Study Record Updates

• Last Update Posted (Actual): March 29, 2024
• Last Update Submitted That Met QC Criteria: March 27, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Stroke; Atrial Fibrillation; Left Atrial Appendage; Thromboembolism; Cardiac Plug; Amulet
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Arrhythmias, Cardiac; Atrial Fibrillation; Thromboembolism
• Other Study ID Numbers: SJM-CIP-10122

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes