Clinical trial NCT02964208: AMPLATZER™ LAA Occluder Post Approval Study (PAS)
Official title: AMPLATZER™ LAA Occluder Post Approval Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Thromboembolism
Stroke
Keywords: Atrial Fibrillation
Stroke
Left Atrial Appendage
Cardiac Plug
Amulet
Thromboembolism
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2016-11-16
Enrollment: 520
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The subject population will include participants that are \> 18 years old and diagnosed with NVAF.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Primary Effectiveness Endpoint 1: Composite Rate of Stroke (Including Ischemic or Hemorrhagic), Systemic Embolism and Cardiovascular or Unexplained Death
timeFrame: Implant through 24 months
measure: Primary Effectiveness Endpoint 2: Composite Rate of Ischemic Stroke or Systemic Embolism
timeFrame: Implant through 24 months
measure: 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
timeFrame: Implant through 7 days
Secondary outcomes:
measure: 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
timeFrame: Implant through 24 months
Other outcomes:
Locations:
city: Rosario
country: Argentina
facility: Instituto Cardiovascular de Rosario
state: Santa Fe
city: Lodelinsart
country: Belgium
facility: Hôpital Civil Marie Curie
state: Hainaut
city: New Westminster
country: Canada
facility: Royal Columbian
state: British Columbia
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
city: Vancouver
country: Canada
facility: St. Paul's Hospital
state: British Columbia
city: Ottawa
country: Canada
facility: Ottawa Heart Institute
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Montreal
country: Canada
facility: Montreal Heart Institute
state: Quebec
city: Montreal
country: Canada
facility: CHUM
state: Quebec
city: Montréal
country: Canada
facility: The Royal Victoria Hospital
state: Quebec
city: Providencia
country: Chile
facility: Instituto Nacional del Torax
state: Santiago
city: Santiago
country: Chile
facility: Hospital Clinico San Borja Arriarán
city: Frankfurt
country: Germany
facility: Cardioangiologisches Centrum am Bethanien Krankenhaus
state: Hesse
city: Bonn
country: Germany
facility: St. Marien-Hospital-Bonn
state: North Rhine-Westphalia
city: Bad Segeberg
country: Germany
facility: Segeberger Kliniken GmbH
state: Schleswig-Holstein
city: Bad Berka
country: Germany
facility: Zentralklinik Bad Berka GmbH
state: Thuringia
city: Napoli
country: Italy
facility: Azienda Ospedaliera Monaldi
state: Campania
city: Torino
country: Italy
facility: Ospedale San Giovanni Bosco
state: Piedmonte
city: Padova
country: Italy
facility: Università degli Studi di Padova
state: Veneto
city: Salamanca
country: Spain
facility: Hospital Universitario de Salamanca
state: Castile And Leon
city: Barcelona
country: Spain
facility: Hospital Clinic I Provincial de Barcelona
state: Catalonia
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro
state: Madrid
Study officials:
affiliation: Abbott
name: Ryan Palmer
role: STUDY_DIRECTOR
References: