This is a prospective, non-randomized, study of the safety and efficacy of the Occlutech® LAA occluder indicated for percutaneous LAA closure in adult male or female patients with atrial fibrillation. Safety and efficacy will be assessed at day 1, 30 and 90, and after 1 year following implantation of an Occlutech® LAA Occluder.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
78
Charité - Universitätsmedizin Berlin
Berlin, Germany
Kardiologie Universitätsklinikum Bonn
Bonn, Germany
Medizinische Klinikum Coburg
Coburg, Germany
CardioVascular Center Frankfurt
Frankfurt, Germany
Successful implantation of the Occlutech LAA closure device with less than 7% occurrence of major complications.
A major complication is defined as an event that results in death, procedure related stroke, systemic embolism, device embolisation, pericardial effusion (cardiac tamponade), or other major bleeding requiring invasive treatment or blood transfusions.
Time frame: 12 months
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Klinik für Innere Medizin Kardiologie Herzzentrum Leipzig GmbH
Leipzig, Germany
University Medical Center of Johannes Gutenberg-University Mainz
Mainz, Germany
NHS Trust (ICHNT) Hammersmith Hospital London
London, United Kingdom