NCT01695564

Safety and Efficacy of Left Atrial Appendage Occlusion Devices

Comparison of Safety and Efficacy of Left Atrial Appendage Occlusion Devices

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 169 (actual)
• Sponsor: Kansas City Heart Rhythm Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
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.
DEVICE	WATCHMAN	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.

Timeline

• Start date: 2012-05-01
• Primary completion: 2017-12-01
• Completion: 2018-02-01
• First posted: 2012-09-28
• Last updated: 2019-05-02

Locations

1 site across 1 country: United States