About this trial
The Left Atrial Appendage Occlusion Registry (LAAO Registry™) is designed to assess the prevalence, demographics, management, and outcomes of patients undergoing percutaneous and epicardial based left atrial appendage occlusion procedures to reduce the risk of stroke. Patient-level data will be submitted by participating hospitals on a quarterly basis to the American College of Cardiology Foundation's National Cardiovascular Data Registry (NCDR). The primary aims of the LAAO Registry are to optimize the outcomes and management of patients through the implementation of evidence-based guideline recommendations in clinical practice, facilitate efforts to improve the quality and safety for patients undergoing percutaneous and epicardial based left atrial appendage procedures, investigate novel quality improvement methods and provide risk-adjusted assessment of patients for comparison with nationwide NCDR data. The secondary purpose of the LAAO Registry is to serve as a rich source of clinical data to support assessments of short- and long-term safety, comparative and cost effectiveness research, and as a scalable data infrastructure for post market studies.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients, 18 years and older, undergoing percutaneous or epicardial left atrial appendage occlusion procedures
Disqualifiers
None
Trial population
All facilities performing percutaneous or epicardial left atrial appendage occlusion procedures.
Trial design
Cohort
Prospective
Treatments tested in this trial
Left Atrial Appendage Occlusion
Procedure/SurgeryPatients undergoing percutaneous/epicardial intervention for left atrial appendage occlusion.
Treatment groups
Trial outcomes
Primary outcomes
Proportion of patients with a major complication
Proportion of patients experiencing any of the following events: Procedure aborted, conversion to open heart, hemorrhagic, ischemic or undetermined stroke, any effusion requiring drainage or surgery, device embolization, systemic embolism, or major bleeding event.
Secondary outcomes
Proportion of patients who experience a stroke (ischemic or hemorrhagic), or systemic embolism or death after left atrial appendage occlusion during the follow up timeframes
Follow up metric for the proportion of patients who experience a stroke (ischemic or hemorrhagic), or systemic embolism or death after left atrial appendage occlusion.
Sponsors and contacts
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