Comparison of Safety and Efficacy of Left Atrial Appendage Occlusion Devices
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Atrial Fibrillation
- Sponsor
- Kansas City Heart Rhythm Institute
- Enrollment
- 169
- Locations
- 1
- Primary Endpoint
- Effect of LAA occlusion by LARIAT device
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Compare effectiveness of LAA occlusion procedure by evaluating LAA jet velocities(Days 0, 90, 180, 365 post-procedure and annually thereafter)