Completed

Comparison of Safety and Efficacy of Left Atrial Appendage Occlusion Devices

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What is being collected

Device Data

+ device Data

Collected from past medical records and data - Retrospective
Device
Who is being recruted

Arrhythmias, Cardiac+3

+ Cardiovascular Diseases

+ Heart Diseases

Over 18 Years
+2 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Case-Control

Comparing exposures between individuals with and without disease in order to identify potential risk factors.
Observational
Study Start: May 2012
See protocol details

Summary

Principal SponsorKansas City Heart Rhythm Institute
Last updated: May 2, 2019
Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 2012

Actual date on which the first participant was enrolled.

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.

NCT01695564
Principal SponsorKansas City Heart Rhythm Institute
Last updated: May 2, 2019
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

169 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Case-Control

These studies compare people who have a disease (cases) with those who don't (controls). The goal is to look back at previous exposures or risk factors to identify what might have contributed to the disease.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Arrhythmias, CardiacCardiovascular DiseasesHeart DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsAtrial Fibrillation

Criteria

1 inclusion criteria required to participate
Patients who have had a LARIAT LAA device occlusion
1 exclusion criteria prevent from participating
Patients who have PFO/ASD/critical carotid artery ( > 70% blockage) disease and hemorrhagic strokes

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

University of Kansas Medical Center

Kansas City, United StatesOpen University of Kansas Medical Center in Google Maps
CompletedOne Study Center