Recruiting

LAAO Registry

Sponsor:

American College of Cardiology

Code:

NCT02699957

Conditions

Atrial Fibrillation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Left Atrial Appendage Occlusion

Study Details

Brief 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.

Conditions

Atrial Fibrillation

Study ID

NCT02699957

Start date

Dec, 2015

Status verified date

Jun, 2026

Completion date

Jan, 2029

Anticipated

Primary completion date

Jan, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Adult patients, 18 years and older, undergoing percutaneous or epicardial left atrial appendage occlusion procedures

Exclusion Criteria:

  • None

Study Design

Enrollment

3000 participants

Anticipated

Interventions and Outcome Measures

Arms

Atrial Fibrillation

Those patients with the condition of atrial fibrillation.

Interventions

Left Atrial Appendage Occlusion

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

Primary outcome measure

  • Proportion of patients with a major complication [ 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. ]

Central Contacts and Locations

Central contacts

Mark Fox, CHC, CHPC

202-375-6305mfox@acc.org

Christina Koutras, RN, BSN

202-375-6387ckoutras@acc.org

Locations

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

Recruiting

Washington D.C., District of Columbia, United States, 20037

Contacts

NCDR Product Support

1-800-257-4737ncdr@acc.org

More Information

Sponsor

American College of Cardiology

Last update posted

Jun 15, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by American College of Cardiology on 2026-06-15.