Safety and Efficacy of Left Atrial Appendage Occlusion Devices

NCT01695564 | Completed

• 1 other identifier: 13240
• Study Type: observational
• Target: 169
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Keywords

atrial enlargement; left atrial appendage

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Compare effectiveness of LAA occlusion procedure by evaluating LAA jet velocities

  Days 0, 90, 180, 365 post-procedure and annually thereafter

Study Arms (2)

WATCHMAN

Patients that had the WATCHMAN device implanted

Device: WATCHMAN

LARIAT LAA Device

patients that had LARIAT LAA device implanted

Device: LARIAT LAA

Interventions

LARIAT LAA DEVICE

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.

LARIAT LAA Device

WATCHMAN DEVICE

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.

WATCHMAN

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who have had a LARIAT LAA device occlusion.

You may qualify if:

• Patients who have had a LARIAT LAA device occlusion

You may not qualify if:

• Patients who have PFO/ASD/critical carotid artery (\>70% blockage) disease and hemorrhagic strokes

Sponsors & Collaborators

• Kansas City Heart Rhythm Institute: lead

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dhanunjaya Lakkireddy, MD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2012
• First Posted: September 28, 2012
• Study Start: May 1, 2012
• Primary Completion: December 1, 2017
• Study Completion: February 1, 2018
• Last Updated: May 2, 2019

Record last verified: 2019-04

Locations

US (1)