Evaluation of the Next Generation WATCHMAN LAA Closure Technology in Non-Valvular AF Patients (EVOLVE)
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 Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Evaluation of the Next Generation WATCHMAN LAA Closure Technology in Non-Valvular AF Patients|
- Successful implantation of the next generation WATCHMAN device without the occurance of life-threatening events caused by the device and/or procedure. [ Time Frame: 12-Months ] [ Designated as safety issue: Yes ]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.
- Device Success [ Time Frame: Implant through 45-Days ] [ Designated as safety issue: No ]Device success, defined as successful delivery and release of the WATCHMAN implant into the LAA, including successful re-capture and retrieval if necessary.
|Study Start Date:||May 2009|
|Estimated Study Completion Date:||September 2012|
|Estimated Primary Completion Date:||September 2012 (Final data collection date for primary outcome measure)|
Device: WATCHMAN LAA Closure Technology
|NA Homolce Hospital|
|Prague, Czech Republic, 150 30|
|Krankenhaus der Barmherzige Bruder|
|Regensburg, Bayern, Germany, 93049|
|Sankt Katharinen Hospital / Cardiovasculares Centrum|
|Frankfurt, Germany, 60389|