Atrial Appendage Closure Prospective Observational Study

Withdrawn

• Conditions: Atrial Fibrillation; Left Atrial Appendage Closure

• Registration Number: NCT02309268
• Lead Sponsor: Virginia Commonwealth University

Brief Summary

The purpose of this research is to monitor how well patients do after surgery for treatment of left atrial appendage (LAA).

Detailed Description

Patients will be followed in an observational study. We propose to do a single follow-up TEE at 3 to 6 months (this is standard of care) to confirm LAA (left atrial appendage) occlusion. The TEE is not mandatory (this is not a clinical trial), but will be strongly recommended to patients to confirm the efficacy of treatment. This will help confirm whether patients may safely remain off anticoagulation. The risks of TEE are a less than 1 in 1000 risk of death, and a 1% or less risk of a major complication, such as esophageal perforation.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2014-08-01
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Study First Submitted QC: 2014-12-02
• Study First Posted: 2014-12-05
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-11
• Last Update Posted: 2015-06-15

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Patients with Atrial fibrillation
• Are poor candidates to take warfarin
• Have elected to undergo a LARIAT procedure

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Exclusion Criteria

• none

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical Progress	At regular visits ( 3 months and annually)	Patients who agree to participate in the registry will allow the Investigators to document their clinical progress and compare their progress to other participants in the study. Meanwhile, the patient will continue to receive routine care from their physician, just as they would if they did not participate in the study. Any information published as a result of this registry, will be kept anonymous. There is no known risk in participating in this study as it is only an observational study.

Trial Locations

Locations (1)

Virginia Medical Center; 🇺🇸 Richmond, Virginia, United States