Safety and Efficacy of Left Atrial Appendage Occlusion Devices

Atrial Fibrillation Clinical Trial

Official title:

Comparison of Safety and Efficacy of Left Atrial Appendage Occlusion Devices

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01695564
• Other study ID #: 13240
• Status: Completed
• Start date: May 2012
• Est. completion date: February 2018

Study information

• Verified date: April 2019
• Source: Kansas City Heart Rhythm Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 169
• Est. completion date: February 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Kansas City Heart Rhythm Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change from Day 0 to Day 90
Primary	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.	Change from Day 0 to 356 post-procedure
Secondary	Compare effectiveness of LAA occlusion procedure by evaluating LAA jet velocities		Days 0, 90, 180, 365 post-procedure and annually thereafter