LARIAT: Atrial Appendage Closure Prospective Observational Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Atrial Fibrillation
- Sponsor
- Virginia Commonwealth University
- Locations
- 1
- Primary Endpoint
- Clinical Progress
- Status
- Withdrawn
- Last Updated
- 10 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients with Atrial fibrillation
- •Are poor candidates to take warfarin
- •Have elected to undergo a LARIAT procedure
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Clinical Progress
Time Frame: 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.