The objective of the AMPLATZER Cardiac Plug (ACP) Registry Long Term Follow-up study is to evaluate long term performance of the ACP in closure of the Left Atrial Appendage (LAA) in subjects with nonvalvular atrial fibrillation and assess adverse events up to two (2) or more years post implant.
Study Type
OBSERVATIONAL
Enrollment
204
Hospital Na Homolce Cardiocentrum
Prague, Czechia
St. Marien-Hospital Bonn
Bonn, Germany
University of Bonn
Bonn, Germany
The rate of occurrence for any reported adverse event experienced by subjects enrolled.
Time frame: Through 2 years
Closure
Defined as absence of flow or flow of ≤3mm jet into the LAA at procedure and at six (6) months as assessed by Transoesophageal Echocardiography (TOE).
Time frame: 6 months
Technical success
Defined as delivery and release of the ACP device, including recapture and/or replacement, as necessary. This success will be calculated among subjects in whom the device enters the body
Time frame: At implant
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Cardiovascular Center Frankfurt
Frankfurt, Germany
Kardiocentrum Frankfurt an der Klinik Rotes Kreuz
Frankfurt, Germany
University Medicine Goettingen
Göttingen, Germany
Asklepios Kliniken GmbH/Asklepios Klinik Harburg
Hamburg, Germany
Stadt Krankenhaus Pirmasens gGmbh
Pirmasens, Germany
Mater Misericordiae University Hospital
Dublin, Ireland
Hospital Universitario Infanta Cristina
Badajoz, Spain
...and 5 more locations