AMPLATZER™ LAA Occluder Post Approval Study (PAS)
Study Details
Study Description
Brief Summary
The AMPLATZER LAA Occluder is a transcatheter, self-expanding nitinol device intended for use in preventing thrombus embolization from the LAA. The purpose of this study is to compile real world outcome data on the use of AMPLATZER LAA Occluder in subjects with non-valvular atrial fibrillation (NVAF)
Condition or Disease | Intervention/Treatment | Phase |
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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 Design
Outcome Measures
Primary Outcome Measures
- The occurrence of one or more adverse events listed in description below [Implant through 24 months]
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
- The occurrence of ischemic stroke or systemic embolism as listed in description below. [Implant through 24 months]
The occurrence of ischemic stroke or systemic embolism at 24 months from the time of enrollment
- The occurrence of a major adverse event within 7 days [Implant through 7 days]
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
Secondary Outcome Measures
- Comparison of the observed rate of ischemic stroke at 24months with the CHA2DS2-VASc predicted rate [Implant through 24 months]
Eligibility Criteria
Criteria
Inclusion Criteria:
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18 years of age or older
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Documented history of nonvalvular atrial fibrillation
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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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Instituto Cardiovascular de Rosario | Rosario | Santa Fe | Argentina | 2000 |
2 | Hôpital Civil Marie Curie | Lodelinsart | Hainaut | Belgium | 6042 |
3 | Royal Columbian | New Westminster | British Columbia | Canada | V3L 3W5 |
4 | Vancouver General Hospital | Vancouver | British Columbia | Canada | V5Z 1M9 |
5 | St. Paul's Hospital | Vancouver | British Columbia | Canada | V6Z 2E8 |
6 | Ottawa Heart Institute | Ottawa | Ontario | Canada | K1Y 4W7 |
7 | St. Michael's Hospital | Toronto | Ontario | Canada | M5B 1W8 |
8 | Montreal Heart Institute | Montreal | Quebec | Canada | H2L 4M1 |
9 | CHUM | Montreal | Quebec | Canada | H2X 3E4 |
10 | The Royal Victoria Hospital | Montréal | Quebec | Canada | H4A 3J1 |
11 | Instituto Nacional del Torax | Providencia | Santiago | Chile | |
12 | Hospital Clinico San Borja Arriarán | Santiago | Chile | 8320000 | |
13 | Cardioangiologisches Centrum am Bethanien Krankenhaus | Frankfurt | Hesse | Germany | 60389 |
14 | St. Marien-Hospital-Bonn | Bonn | North Rhine-Westphalia | Germany | 53115 |
15 | Segeberger Kliniken GmbH | Bad Segeberg | Schleswig-Holstein | Germany | 23795 |
16 | Zentralklinik Bad Berka GmbH | Bad Berka | Thuringia | Germany | 99438 |
17 | Azienda Ospedaliera Monaldi | Napoli | Campania | Italy | 80131 |
18 | Ospedale San Giovanni Bosco | Torino | Piedmonte | Italy | 10154 |
19 | Università degli Studi di Padova | Padova | Veneto | Italy | 35128 |
20 | Hospital Universitario de Salamanca | Salamanca | Castile And Leon | Spain | 37007 |
21 | Hospital Clinic I Provincial de Barcelona | Barcelona | Catalonia | Spain | 8028 |
22 | Hospital Universitario Puerta de Hierro | Majadahonda | Madrid | Spain | 28222 |
Sponsors and Collaborators
- Abbott Medical Devices
Investigators
- Study Director: Maren Wagner, Abbott
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SJM-CIP-10122