Safety and Efficacy of Left Atrial Appendage Occlusion Devices

Completed

• Conditions: Atrial Fibrillation
• Interventions: Device: WATCHMAN; Device: LARIAT LAA

• Registration Number: NCT01695564
• Lead Sponsor: Kansas City Heart Rhythm Institute

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-07-05
• Study First Submitted QC: 2012-09-26
• Study First Posted: 2012-09-28
• Primary Completion: 2017-12
• Study Completion: 2018-02
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-30
• Last Update Posted: 2019-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 169

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
WATCHMAN	WATCHMAN	Patients that had the WATCHMAN device implanted
LARIAT LAA Device	LARIAT LAA	patients that had LARIAT LAA device implanted

Primary Outcome Measures

Name	Time	Method
Effect of LAA occlusion by LARIAT device	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

Name	Time	Method
Compare effectiveness of LAA occlusion procedure by evaluating LAA jet velocities	Days 0, 90, 180, 365 post-procedure and annually thereafter

Trial Locations

Locations (1)

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States