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Trial record 1 of 1 for:    NCT02699957
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Left Atrial Appendage Occlusion Registry (LAAO Registry)

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ClinicalTrials.gov Identifier: NCT02699957
Recruitment Status : Recruiting
First Posted : March 7, 2016
Last Update Posted : July 8, 2020
Sponsor:
Information provided by (Responsible Party):
American College of Cardiology

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.

Condition or disease Intervention/treatment
Atrial Fibrillation Procedure: Left Atrial Appendage Occlusion

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Left Atrial Appendage Occlusion Registry (LAAO Registry)
Study Start Date : December 2015
Estimated Primary Completion Date : January 2026
Estimated Study Completion Date : January 2026

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Atrial Fibrillation
Those patients with the condition of atrial fibrillation.
Procedure: Left Atrial Appendage Occlusion
Patients undergoing percutaneous/epicardial intervention for left atrial appendage occlusion.




Primary Outcome Measures :
  1. 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. ]
    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 Outcome Measures :
  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 [ Time Frame: Assessed at 45 day, 6 month, 1 year and 2 year follow up ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All facilities performing percutaneous or epicardial left atrial appendage occlusion procedures.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02699957


Contacts
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Contact: Mark Fox, CHC, CHPC 202-375-6305 mfox@acc.org
Contact: Christina Koutras, RN, BSN 202-375-6387 ckoutras@acc.org

Locations
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United States, District of Columbia
American College of Cardiology/National Cardiovascular Data Registry (NCDR) Recruiting
Washington, District of Columbia, United States, 20037
Contact: NCDR Product Support    800-257-4737    ncdr@acc.org   
Sponsors and Collaborators
American College of Cardiology
Investigators
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Study Chair: Paul Varosy, MD VA Eastern Colorado Health Care System
Additional Information:
Study Data/Documents: Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: Data Collection Form
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: Data Dictionary
Element definitions and coding instructions.

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Responsible Party: American College of Cardiology
ClinicalTrials.gov Identifier: NCT02699957    
Other Study ID Numbers: LAAO Registry
First Posted: March 7, 2016    Key Record Dates
Last Update Posted: July 8, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes