Left Atrial Appendage Occlusion Registry (LAAO Registry)

NCT02699957 | Recruiting

• 1 other identifier: LAAO Registry
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

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

Outcome Measures

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.

  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

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

Study Arms (1)

Atrial Fibrillation

Those patients with the condition of atrial fibrillation.

Procedure: Left Atrial Appendage Occlusion

Interventions

Left Atrial Appendage Occlusion PROCEDURE

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

Atrial Fibrillation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All facilities performing percutaneous or epicardial left atrial appendage occlusion procedures.

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• American College of Cardiology: lead

Study Sites (1)

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

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

RECRUITING

Related Links

• National Cardiovascular Data Registry (NCDR). Click this link for more information on the registry.

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Left Atrial Appendage Closure

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cardiac Catheterization; Catheterization; Therapeutics; Investigative Techniques

Study Officials

• Paul Varosy, MD

  VA Eastern Colorado Health Care System

  STUDY CHAIR

Central Study Contacts

Mark Fox, CHC, CHPC

CONTACT

202-375-6305; mfox@acc.org

Christina Koutras, RN, BSN

CONTACT

202-375-6387; ckoutras@acc.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2016
• First Posted: March 7, 2016
• Study Start: December 1, 2015
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: April 18, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)