Safety and Efficacy of Left Atrial Appendage Occlusion Devices

Study Overview
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Brief Summary
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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.

Official Title
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Comparison of Safety and Efficacy of Left Atrial Appendage Occlusion Devices

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Device: LARIAT LAA
* Device: WATCHMAN


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who have had a LARIAT LAA device occlusion Exclusion Criteria: Patients who have PFO/ASD/critical carotid artery (>70% blockage) disease and hemorrhagic strokes

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| WATCHMAN<br>Patients that had the WATCHMAN device implanted | Device: WATCHMAN<br>* 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.<br>|
| LARIAT LAA Device<br>patients that had LARIAT LAA device implanted | Device: LARIAT LAA<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of LAA occlusion by LARIAT device | 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. | Change from Day 0 to Day 90 | 
| Effect of LAA occlusion by LARIAT device | 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. | Change from Day 0 to 356 post-procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare effectiveness of LAA occlusion procedure by evaluating LAA jet velocities |  | Days 0, 90, 180, 365 post-procedure and annually thereafter | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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atrial enlargement, left atrial appendage