Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT02699957 |
| Other study ID # |
LAAO Registry |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
December 2015 |
| Est. completion date |
January 2026 |
Study information
| Verified date |
April 2024 |
| Source |
American College of Cardiology |
| Contact |
Mark Fox, CHC, CHPC |
| Phone |
202-375-6305 |
| Email |
mfox[@]acc.org |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial 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.
Description:
Hospitals join the Left Atrial Appendage Occlusion Registry (LAAO Registry) by agreeing to
the terms of a specific contract that outlines the obligations of each party and the annual
fees for participation. In addition, participating sites sign a Business Associate Agreement
with the American College of Cardiology (ACC) as per the requirements of the Health Insurance
Portability and Accountability Act of 1996 (HIPAA).
The LAAO Registry dataset, comprised of approximately 300 data elements, was created by a
panel of experts using available American College of Cardiology (ACC), Heart Rhythm Society
(HRS), and Society for Cardiovascular Angiography and Interventions (SCAI) societal overview
document guidance, data elements and definitions, previous trial data elements, and other
evidentiary sources. Protected Health Information (PHI), such as social security number, is
collected. The intent for collection of PHI is to allow for complete follow-up and tracking
of the patient, to assist data managers in correcting data collection errors and improving
data quality, for future registry interoperability and the potential for future generation of
patient-level drill downs in Quality and Outcomes Reports (see section 11, Data Analysis and
Statistical Considerations). Registry sites can opt out of transmitting direct identifiers to
the National Cardiovascular Data Registry (NCDR), so inclusion of direct identifiers in the
registry is at the discretion of the registry site. When using the NCDR web-based data
collection tool, direct identifiers are entered but a partition between the data collection
process and the data warehouse maintains the direct identifiers separate from the analysis
datasets. The minimum level of PHI transmitted to the ACC when a participant opts out of
submitting direct identifiers meets the definition of a Limited Dataset as such term is
defined by the Health Insurance Portability and Accountability Act of 1996.
Data required for registry participation are collected retrospectively from existing medical
records or concurrently in the normal course of treatment. The Societal Document and safety
recommendations for left atrial appendage occlusion recommend additional testing and contact
with the patient outside the hospital episode of care at 45 days, 6 months, 1 year and 2
years post-procedure. All registry data (in-hospital and follow-up) is captured by
participating sites using an electronic data collection tool provided by the LAAO Registry or
in the future the option will be available for collecting data using a certified software
application that has been reviewed and certified as compliant with the transmissions
specifications established by the ACC for the LAAO Registry.
Upon completion of a call for data window, participants prepare a data submission by
exporting the data from their data collection mechanism and uploading their data to a secure
https server at the ACC using approved encryption software with the highest encryption that
is allowed.
In recognition of the importance of data quality to all of its registry products, and to
ensure that data submitted to the NCDR are complete, consistent, and accurate, a Data Quality
Program was formally established by the NCDR in 2004. Upon receipt of the LAAO Registry data
submission, the ACC reviews the data electronically and reports back coding errors. Such
electronic checks verify consistency and completeness and allow participants to have ample
opportunity to submit data until it satisfies consistency and completion thresholds. The
report produced from these data checks is called a Data Quality Report (DQR).
The DQR provides the participant with a confidential analysis of their data submission's
completeness, and is used by the participant to help prioritize data cleaning efforts and to
assess the necessity for re-submission.
Once the data meets the data quality thresholds, an Outcomes Report is produced. The Outcomes
Report aggregates the participant's data and provides a comparison group (usually procedure
volume based) and national comparison.
The NCDR understands the need to ensure the data submitted to the LAAO Registry is accurate
and it has launched a national on-site and off-site audit program whereas a random set of
participants participate in an on-site or off-site audit to confirm the data submitted to the
registry is consistent with data in the medical record or source documentation.
