Safety and Efficacy of Left Atrial Appendage Occlusion Devices

April 30, 2019 updated by: Kansas City Heart Rhythm Institute

Comparison of 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

169

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who have had a LARIAT LAA device occlusion.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
WATCHMAN
Patients that had the WATCHMAN device implanted
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.
LARIAT LAA Device
patients that had LARIAT LAA device implanted
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from Day 0 to Day 90
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.
Change from Day 0 to 356 post-procedure

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kansas City Heart Rhythm Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

February 1, 2018

Study Registration Dates

First Submitted

July 5, 2012

First Submitted That Met QC Criteria

September 26, 2012

First Posted (Estimate)

September 28, 2012

Study Record Updates

Last Update Posted (Actual)

May 2, 2019

Last Update Submitted That Met QC Criteria

April 30, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13240

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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