RecruitingNCT02699957

Left Atrial Appendage Occlusion Registry (LAAO Registry)


Sponsor

American College of Cardiology

Enrollment

3,000 participants

Start Date

Dec 1, 2015

Study Type

OBSERVATIONAL

Conditions

Summary

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is a national registry tracking patients who have had a small device implanted to close off a part of the heart called the left atrial appendage (LAA) — a procedure done to prevent blood clots and reduce stroke risk in people with atrial fibrillation (an irregular heartbeat) — to evaluate how safe and effective these devices are over time. **You may be eligible if...** - You have atrial fibrillation (an irregular heartbeat) and are at risk for stroke - You are not able to take blood thinners long-term (such as warfarin), or your doctor recommends the LAA closure device as an alternative - You have had or are scheduled to have a left atrial appendage occlusion device implanted - You are being treated at a participating medical center **You may NOT be eligible if...** - You do not have atrial fibrillation - You are not having or have not had the LAA closure procedure - You do not consent to registry data collection Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURELeft Atrial Appendage Occlusion

Patients undergoing percutaneous/epicardial intervention for left atrial appendage occlusion.


Locations(1)

American College of Cardiology/National Cardiovascular Data Registry (NCDR)

Washington D.C., District of Columbia, United States

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NCT02699957


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