Safety and Efficacy of Left Atrial Appendage Occlusion Devices

Comparison of Safety and Efficacy of Left Atrial Appendage Occlusion Devices

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01695564

Enrollment

169

Registered

2012-09-28

Start date

2012-05-31

Completion date

2018-02-28

Last updated

2019-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Keywords

atrial enlargement, left atrial appendage

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.

Interventions

DEVICELARIAT 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.

DEVICEWATCHMAN

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.

Study design

Observational model

CASE_CONTROL

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Effect of LAA occlusion by LARIAT device	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.

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026