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Trials / Withdrawn

WithdrawnNCT02309268

Atrial Appendage Closure Prospective Observational Study

LARIAT: Atrial Appendage Closure Prospective Observational Study

Status
Withdrawn
Phase
Study type
Observational
Enrollment
0 (actual)
Sponsor
Virginia Commonwealth University · Academic / Other
Sex
All
Age
21 Years
Healthy volunteers
Not accepted

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

Timeline

Start date
2012-06-01
Primary completion
2014-10-01
Completion
2014-10-01
First posted
2014-12-05
Last updated
2015-06-15

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02309268. Inclusion in this directory is not an endorsement.

Atrial Appendage Closure Prospective Observational Study (NCT02309268) · Clinical Trials Directory