NCT03428048 Cardiovascular Innovation & Research Institute 's NEXUS Registry, the Whole is Greater Than the Parts.
| NCT ID | NCT03428048 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Cardiovascular Innovation and Research Institute |
| Condition | Coronary Artery Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2016-03 |
| Primary Completion | 2026-03 |
Trial Parameters
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Brief Summary
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. The 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. The 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, the investigators 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.
Eligibility Criteria
Inclusion Criteria: Candidates will be included in the study only if all the following conditions are met: 1. Age \>18 years 2. The subject has been informed of the nature of the study, agrees to its provisions, is able to comprehend, and has provided informed consent. 3. The subject is available for follow-up. 4. The subject has a diagnosis of coronary artery disease or Afib. Exclusion Criteria: Candidates will be excluded from the study if any of the following conditions are present: 1. Failure and / or inability and / or unwillingness to provide informed consent. 2. Likely problems, in the judgement of the investigators, with maintaining follow-up.