Safety and Efficacy of Left Atrial Appendage Occlusion Devices

Kansas City Heart Rhythm Institute169 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

169

Conditions

Atrial Fibrillation

Interventions

LARIAT LAADEVICE

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.

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Kansas Medical Center

Kansas City, Kansas, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: Change from Day 0 to 356 post-procedure

Secondary Outcomes

Compare effectiveness of LAA occlusion procedure by evaluating LAA jet velocities

Time frame: Days 0, 90, 180, 365 post-procedure and annually thereafter

Data from ClinicalTrials.gov

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