Skip to main content
OpenTrials
Completed

NCT Number: NCT01695564

Safety and Efficacy of Left Atrial Appendage Occlusion Devices

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LARIAT LAA

Device

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.

WATCHMAN

Device

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.

Primary outcomes

  1. Effect of LAA occlusion by LARIAT device

    Time frame: 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.

  2. 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

  1. Compare effectiveness of LAA occlusion procedure by evaluating LAA jet velocities

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

Sponsors and collaborators

Lead sponsor

Kansas City Heart Rhythm Institute

Other

Registry information

Official study title

Comparison of Safety and Efficacy of Left Atrial Appendage Occlusion Devices

Important dates

Study start
2012
Primary completion
2017
Study completion
2018
First posted
Sep 28, 2012
Registry last updated
May 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.