Study Results
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View full resultsBasic Information
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COMPLETED
520 participants
OBSERVATIONAL
2016-12-08
2022-08-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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LAA Occluder PAS
Subjects who were treated with AMPLATZER LAA Occluders will be included.
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Abbott Medical Devices
INDUSTRY
Responsible Party
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Principal Investigators
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Ryan Palmer
Role: STUDY_DIRECTOR
Abbott
Locations
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Instituto Cardiovascular de Rosario
Rosario, Santa Fe Province, Argentina
Hôpital Civil Marie Curie
Lodelinsart, Hainaut, Belgium
Royal Columbian
New Westminster, British Columbia, Canada
Vancouver General Hospital
Vancouver, British Columbia, Canada
St. Paul's Hospital
Vancouver, British Columbia, Canada
Ottawa Heart Institute
Ottawa, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
Montreal Heart Institute
Montreal, Quebec, Canada
CHUM
Montreal, Quebec, Canada
The Royal Victoria Hospital
Montreal, Quebec, Canada
Instituto Nacional del Torax
Providencia, Santiago Metropolitan, Chile
Hospital Clinico San Borja Arriarán
Santiago, , Chile
Cardioangiologisches Centrum am Bethanien Krankenhaus
Frankfurt am Main, Hesse, Germany
St. Marien-Hospital-Bonn
Bonn, North Rhine-Westphalia, Germany
Segeberger Kliniken GmbH
Bad Segeberg, Schleswig-Holstein, Germany
Zentralklinik Bad Berka GmbH
Bad Berka, Thuringia, Germany
Azienda Ospedaliera Monaldi
Napoli, Campania, Italy
Ospedale San Giovanni Bosco
Torino, Piedmonte, Italy
Università degli Studi di Padova
Padua, Veneto, Italy
Hospital Universitario de Salamanca
Salamanca, Castille and León, Spain
Hospital Clinic I Provincial de Barcelona
Barcelona, Catalonia, Spain
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, Spain
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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SJM-CIP-10122
Identifier Type: -
Identifier Source: org_study_id
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