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Safety and Efficacy of Left Atrial Appendage Occlusion Devices

This study is enrolling participants by invitation only.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01695564
First Posted: September 28, 2012
Last Update Posted: October 18, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dhanunjaya Lakkireddy, MD, FACC, University of Kansas Medical Center
  Purpose

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.


Condition Intervention
Atrial Fibrillation Device: LARIAT LAA Device: WATCHMAN

Study Type: Observational
Study Design: Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Comparison of Safety and Efficacy of Left Atrial Appendage Occlusion Devices

Resource links provided by NLM:


Further study details as provided by Dhanunjaya Lakkireddy, MD, FACC, University of Kansas Medical Center:

Primary Outcome Measures:
  • 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.

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

Estimated Enrollment: 150
Study Start Date: May 2012
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who have had a LARIAT LAA device occlusion.
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01695564


Locations
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
Dhanunjaya Lakkireddy, MD, FACC
Investigators
Principal Investigator: Dhanunjaya Lakkireddy, MD University of Kansas Medical Center
  More Information

Responsible Party: Dhanunjaya Lakkireddy, MD, FACC, Professor of Medicine, University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT01695564     History of Changes
Other Study ID Numbers: 13240
First Submitted: July 5, 2012
First Posted: September 28, 2012
Last Update Posted: October 18, 2017
Last Verified: October 2017

Keywords provided by Dhanunjaya Lakkireddy, MD, FACC, University of Kansas Medical Center:
atrial enlargement
left atrial appendage

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes