Safety and Efficacy of Left Atrial Appendage Occlusion Devices
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|ClinicalTrials.gov Identifier: NCT01695564|
Recruitment Status : Enrolling by invitation
First Posted : September 28, 2012
Last Update Posted : October 18, 2017
Atrial fibrillation (AF) is the most common cardiac rhythm disorder in clinical practice. In the last two decades the number of hospitalizations for AF has increased two- to three-fold. More than 6 million people worldwide suffer from atrial fibrillation (AF), a cardiac disorder that results in systemic emboli. Patients with AF are 5 times more likely to have a stroke compared with those without AF.
This registry will collection information on two devices that are used to treat AF. The WATCHMAN and LARIAT. The differences in techniques and subsequent effects of the two devices on outcomes related to AF has not been studied. This study will look to compare the two devices to see how the outcomes may vary.
|Condition or disease||Intervention/treatment|
|Atrial Fibrillation||Device: LARIAT LAA Device: WATCHMAN|
|Study Type :||Observational|
|Estimated Enrollment :||150 participants|
|Official Title:||Comparison of Safety and Efficacy of Left Atrial Appendage Occlusion Devices|
|Study Start Date :||May 2012|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||May 2018|
Patients that had the WATCHMAN device implanted
The WATCHMAN is an expandable device deployed in the LAA via a trans-septal catheter. The implanted device has a self-expanding nitinol frame to secure it in the LAA. The fabric of the WATCHMAN device is permeable to blood.
LARIAT LAA Device
patients that had LARIAT LAA device implanted
Device: LARIAT LAA
The LARIAT snare device is an over-the-wire device guided over the LAA to enable ligation of the LAA. The LARIAT can be opened and closed as desired for ideal positioning without risk of suture deployment.
- Effect of LAA occlusion by LARIAT device [ Time Frame: Change from Day 0 to Day 90 ]This registry will provide data on patient outcomes at different times during follow up. This includes: changes in the appendage size, shape and patients medical history.
- Effect of LAA occlusion by LARIAT device [ Time Frame: Change from Day 0 to 356 post-procedure ]This registry will provide data on patient outcomes at different times during follow up.This includes: changes in the appendage size, shape and patients medical history.
- Compare effectiveness of LAA occlusion procedure by evaluating LAA jet velocities [ Time Frame: Days 0, 90, 180, 365 post-procedure and annually thereafter ]
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): NCT01695564
|United States, Kansas|
|University of Kansas Medical Center|
|Kansas City, Kansas, United States, 66160|
|Principal Investigator:||Dhanunjaya Lakkireddy, MD||University of Kansas Medical Center|