The primary objective of this study is to assess the efficacy and safety of using intra-procedural intracardiac echocardiography (ICE) for WATCHMAN FLX Device implants in subjects with non-valvular atrial fibrillation to reduce the risk of stroke.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
use of intra-procedural intracardiac echocardiography during Watchman FLX devices
Aarhus Universitetshospital
Skejby, Denmark
Fondazione Toscana Gabriele Monasterio
Massa, Italy
Ospedale dell'Angelo
Mestre, Italy
Centro Cardiologico Fondazione Monzino
Milan, Italy
Rate of Device Leak
Rate of significant leak (\>5 mm) as assessed by TEE at 45 days' post-implant.
Time frame: 45 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Ospedale San Bortolo
Vicenza, Italy
Hospital de Sant Pau
Barcelona, Spain
John Radcliffe
Oxford, United Kingdom