Cardiovascular Innovation & Research Institute 's NEXUS Registry, the Whole is Greater Than the Parts.
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Information gathered from the patients via a disease specific questionnaire will be married to data from the National Cardiovascular Data Registry (NCDR®). Details will be continuously analyzed and used to direct quality of care at our center. Our institution is categorized as a low-volume institution for percutaneous coronary intervention (PCI) for coronary artery disease treatment as well as surgical and endocardial ablation for the management of atrial fibrillation (Afib). The association between operator volume and quality has primarily focused on rare complications, such as mortality. Our aim is to highlight the advantages of receiving care close to home. A benefit of offering the procedures to treat diseases at centers that have lower volumes is to improve patients' outcomes while also providing more convenient access to quality care. The key outcome from the patients' experience is alleviation of their symptoms while increasing function and quality of life. To date, there have been no studies documenting the health status benefits of PCI and surgical / endocardial ablation for coronary artery disease and Afib, respectively with low- volume operators. In this study, we sought to examine the feasibility of implementing patient-reported outcomes into clinical care and to demonstrate evidence of benefits, from patients' perspectives, of receiving treatment by low-volume operators.
NEXUS Registry: An Outcomes Database Which Tracks Patient -Reported Outcomes After Percutaneous Coronary Intervention for Coronary Artery Disease Along With Surgical and Subcutaneous Ablation for the Management of Atrial Fibrillation.
Actual Study Start Date
Estimated Primary Completion Date
Estimated Study Completion Date
Resource links provided by the National Library of Medicine
The primary outcome is the 6-month change in SAQ mean score (6-month mean - baseline mean). [ Time Frame: Initial Analysis at baseline (administered pre-PCI procedure or during in-patient status), follow-up intervals are 6 months after then annually thereafter for up to 10 years. ]
For adults with coronary artery disease who experience PCI the key outcome, from patients' perspectives, is the alleviation of their symptoms, function, and quality of life, which provides rationale for using the 6-month change in SAQ as the primary outcome.
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
All comers outcomes registry
Candidates will be included in the study only if all the following conditions are met:
Age >18 years
The subject has been informed of the nature of the study, agrees to its provisions, is able to comprehend, and has provided informed consent.
The subject is available for follow-up.
The subject has a diagnosis of coronary artery disease or Afib.
Candidates will be excluded from the study if any of the following conditions are present:
Failure and / or inability and / or unwillingness to provide informed consent.
Likely problems, in the judgement of the investigators, with maintaining follow-up.