Atrial Appendage Closure Prospective Observational Study

Atrial Fibrillation Clinical Trial

— LARIAT  

Official title:

LARIAT: Atrial Appendage Closure Prospective Observational Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02309268
• Other study ID #: LARIAT
• Status: Withdrawn
• Phase: N/A
• First received: August 1, 2014
• Last updated: June 11, 2015
• Start date: June 2012
• Est. completion date: October 2014

Study information

• Verified date: June 2015
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Patients with Atrial fibrillation

• Are poor candidates to take warfarin

• Have elected to undergo a LARIAT procedure

Exclusion Criteria:

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Atrial Fibrillation
• Left Atrial Appendage Closure

Locations

Country	Name	City	State
United States	Virginia Medical Center	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Progress	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.	At regular visits ( 3 months and annually)	No