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Cardiovascular Innovation & Research Institute 's NEXUS Registry, the Whole is Greater Than the Parts.
NCT03428048 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- PROCEDURE Hybrid procedure
- PROCEDURE Endocardial ablations
- PROCEDURE left atrial appendage occlusion
Study Locations (1)
Colorado
- Valley View Hospital — Glenwood Springs
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,000 participants |
| Start Date | 2016-03 |
| Est. Completion | 2030-03 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03428048
The ClinicalTrials.gov registry entry for NCT03428048 describes a study currently listed as recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,000 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cardiovascular Innovation and Research Institute, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Coronary Artery Disease appearing as the primary indexed condition, and to 3 interventions — of which Hybrid procedure is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03428048 reports 1 study location spanning 1 distinct geographic area — top geographies include Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03428048 about?
NCT03428048 is a clinical study titled "Cardiovascular Innovation & Research Institute 's NEXUS Registry, the Whole is Greater Than the Parts.". 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 instituti...
What is the current status of trial NCT03428048?
This trial is currently recruiting. The enrollment target is 1,000 participants. The study started on 2016-03. Estimated completion is 2030-03.
What conditions does trial NCT03428048 study?
This clinical trial studies the following conditions: Coronary Artery Disease, Atrial Fibrillation (AF). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03428048?
The interventions under investigation include: Hybrid procedure (PROCEDURE), Endocardial ablations (PROCEDURE), left atrial appendage occlusion (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03428048?
This trial is sponsored by Cardiovascular Innovation and Research Institute, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03428048 being conducted?
This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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