Left Atrial Appendage Occlusion Registry (LAAO Registry)

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAmerican College of Cardiology

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Left Atrial Appendage Occlusion

    Procedure/Surgery

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

Treatment groups

3,000 Participants
are divided into 1 treatment group
Group A: Atrial Fibrillation1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Assessed in hospital for any occurence from the start of procedure date and time until discharge date and time, assessed up to 24 months. Reported quarterly.

Secondary outcomes

1

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.

Time frame
Assessed at 45 day, 6 month, 1 year and 2 year follow up

Other outcomes

Sponsors and contacts

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