Atrial Appendage Closure Prospective Observational Study

NCT ID: NCT02309268

Last Updated: 2015-06-15

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2014-10-31

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.

Conditions

Atrial Fibrillation; Left Atrial Appendage Closure

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• none

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Virginia Commonwealth University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

kenneth A Ellenbogen, MD

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

Virginia Medical Center

Richmond, Virginia, United States

Countries

United States

Other Identifiers

LARIAT

Identifier Type: -

Identifier Source: org_study_id