AMPLATZER™ LAA Occluder Post Approval Study (PAS)
1 other identifier
observational
520
7 countries
22
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2016
Longer than P75 for all trials
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 6, 2016
CompletedFirst Posted
Study publicly available on registry
November 16, 2016
CompletedStudy Start
First participant enrolled
December 8, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 13, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 10, 2022
CompletedResults Posted
Study results publicly available
March 29, 2024
CompletedMarch 29, 2024
March 1, 2024
5.5 years
October 6, 2016
August 18, 2023
March 27, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 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
Implant through 24 months
Study Arms (1)
LAA Occluder PAS
Subjects who were treated with AMPLATZER LAA Occluders will be included.
Interventions
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.
Eligibility Criteria
The subject population will include participants that are \> 18 years old and diagnosed with NVAF.
You may qualify if:
- 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
You may not qualify if:
- Women of childbearing potential who are, or plan to become, pregnant during the time of the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
Instituto Cardiovascular de Rosario
Rosario, Santa Fe Province, 2000, Argentina
Hôpital Civil Marie Curie
Lodelinsart, Hainaut, 6042, Belgium
Royal Columbian
New Westminster, British Columbia, V3L 3W5, Canada
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9, Canada
St. Paul's Hospital
Vancouver, British Columbia, V6Z 2E8, Canada
Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7, Canada
St. Michael's Hospital
Toronto, Ontario, M5B 1W8, Canada
Montreal Heart Institute
Montreal, Quebec, H2L 4M1, Canada
CHUM
Montreal, Quebec, H2X 3E4, Canada
The Royal Victoria Hospital
Montreal, Quebec, H4A 3J1, Canada
Instituto Nacional del Torax
Providencia, Santiago Metropolitan, Chile
Hospital Clinico San Borja Arriarán
Santiago, 8320000, Chile
Cardioangiologisches Centrum am Bethanien Krankenhaus
Frankfurt am Main, Hesse, 60389, Germany
St. Marien-Hospital-Bonn
Bonn, North Rhine-Westphalia, 53115, Germany
Segeberger Kliniken GmbH
Bad Segeberg, Schleswig-Holstein, 23795, Germany
Zentralklinik Bad Berka GmbH
Bad Berka, Thuringia, 99438, Germany
Azienda Ospedaliera Monaldi
Napoli, Campania, 80131, Italy
Ospedale San Giovanni Bosco
Torino, Piedmonte, 10154, Italy
Università degli Studi di Padova
Padua, Veneto, 35128, Italy
Hospital Universitario de Salamanca
Salamanca, Castille and León, 37007, Spain
Hospital Clinic I Provincial de Barcelona
Barcelona, Catalonia, 8028, Spain
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, 28222, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Ryan Gage
- Organization
- Abbott
Study Officials
- STUDY DIRECTOR
Ryan Palmer
Abbott
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 6, 2016
First Posted
November 16, 2016
Study Start
December 8, 2016
Primary Completion
June 13, 2022
Study Completion
August 10, 2022
Last Updated
March 29, 2024
Results First Posted
March 29, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will not share