Clinical trial NCT02699957: Left Atrial Appendage Occlusion Registry (LAAO Registry)
Official title: Left Atrial Appendage Occlusion Registry (LAAO Registry)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atrial Fibrillation
Lead sponsor: American College of Cardiology
Sponsor class: OTHER
First posted: 2016-03-07
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All facilities performing percutaneous or epicardial left atrial appendage occlusion procedures.

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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* None

Primary outcomes:
measure: Proportion of patients with a major complication
timeFrame: 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:
measure: 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
timeFrame: Assessed at 45 day, 6 month, 1 year and 2 year follow up
Other outcomes:
Locations:
city: Washington
country: United States
facility: American College of Cardiology/National Cardiovascular Data Registry (NCDR)
state: District of Columbia
Study officials:
affiliation: VA Eastern Colorado Health Care System
name: Paul Varosy, MD
role: STUDY_CHAIR
References: