Safety and Efficacy of Left Atrial Appendage Occlusion Devices

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Dhanunjaya Lakkireddy, MD, FACC, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier:
NCT01695564
First received: July 5, 2012
Last updated: August 13, 2013
Last verified: August 2013
  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 University of Kansas:

Primary Outcome Measures:
  • Effect of LAA occlusion by LARIAT device [ Time Frame: Change from Day 0 to Day 90 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: May 2012
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: May 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Dhanunjaya Lakkireddy, MD, FACC, Professor of Medicine, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier: NCT01695564     History of Changes
Other Study ID Numbers: 13240
Study First Received: July 5, 2012
Last Updated: August 13, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Kansas:
atrial enlargement
left atrial appendage

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

ClinicalTrials.gov processed this record on April 17, 2014