Evaluation of the Next Generation WATCHMAN LAA Closure Technology in Non-Valvular AF Patients (EVOLVE) (EVOLVE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01196897|
Recruitment Status : Completed
First Posted : September 9, 2010
Last Update Posted : December 8, 2015
|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation||Device: WATCHMAN LAA Closure Technology (Gen 4.0)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||69 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of the Next Generation WATCHMAN LAA Closure Technology in Non-Valvular AF Patients|
|Study Start Date :||May 2009|
|Actual Primary Completion Date :||September 2012|
|Actual Study Completion Date :||November 2013|
Experimental: Implantable device
WATCHMAN LAA Closure Technology (Gen 4.0)
Device: WATCHMAN LAA Closure Technology (Gen 4.0)
Implantation of the WATCHMAN device into the left atrial appendage.
- 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 ]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 ]Device success, defined as successful delivery and release of the WATCHMAN implant into the LAA, including successful re-capture and retrieval if necessary.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01196897
|NA Homolce Hospital|
|Prague, Czech Republic, 150 30|
|Krankenhaus der Barmherzige Bruder|
|Regensburg, Bayern, Germany, 93049|
|Sankt Katharinen Hospital / Cardiovasculares Centrum|
|Frankfurt, Germany, 60389|
|Principal Investigator:||Vivek Reddy, MD||Na Homolce Hospital|