This study will evaluate the next generation WATCHMAN Left Atrial Appendage (LAA) Closure Device as implanted in patients with non-valvular atrial fibrillation (AF) with a CHADS2 stroke risk stratification score of 1 or greater. This is a prospective, non-randomized study to evaluate the initial use of the next generation WATCHMAN Device.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
69
Implantation of the WATCHMAN device into the left atrial appendage.
NA Homolce Hospital
Prague, Czechia
Krankenhaus der Barmherzige Bruder
Regensburg, Bavaria, Germany
Sankt Katharinen Hospital / Cardiovasculares Centrum
Frankfurt, Germany
Successful implantation of the next generation WATCHMAN device without the occurance of life-threatening events caused by the device and/or procedure.
The implantation of the next generation WATCHMAN device without the occurrence of life-threatening events caused by the device and/or the procedure. These events may include device embolization requiring retrieval, bleeding events such as pericardial effusion requiring drainage, cardiac perforation requiring operation, cranial bleeding events due to any source, and any systemic embolic events related to the device or procedure.
Time frame: 12-Months
Device Success
Device success, defined as successful delivery and release of the WATCHMAN implant into the LAA, including successful re-capture and retrieval if necessary.
Time frame: Implant through 45-Days
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