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Atrial Appendage Closure Prospective Observational Study

LARIAT: Atrial Appendage Closure Prospective Observational Study

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02309268
Acronym
LARIAT
Enrollment
0
Registered
2014-12-05
Start date
2012-06-30
Completion date
2014-10-31
Last updated
2015-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation, Left Atrial Appendage Closure

Keywords

left atrial appendage closure

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.

Interventions

None listed

Sponsors

Virginia Commonwealth University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* none

Design outcomes

Primary

MeasureTime frameDescription
Clinical ProgressAt 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026