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NCT03428048 · ClinicalTrials.gov registry record

Cardiovascular Innovation & Research Institute 's NEXUS Registry, the Whole is Greater Than the Parts.

A clinical trial of Coronary Artery Disease and Atrial Fibrillation (AF), sponsored by Cardiovascular Innovation and Research Institute.

Recruiting
Registry status
1,000
Enrollment target
1
Study location

NCT03428048 is a study of Coronary Artery Disease and Atrial Fibrillation (AF) that is actively recruiting participants, run by Cardiovascular Innovation and Research Institute. The registered enrollment target is 1,000 participants, below the 1,282-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (22% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT03428048, a study of Coronary Artery Disease and Atrial Fibrillation (AF), is actively recruiting participants, sponsored by Cardiovascular Innovation and Research Institute.

RECRUITING
Registry status
1,000 participants
Enrollment target
1
Study location

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.

Interventions

  • PROCEDURE Hybrid procedure
  • PROCEDURE Endocardial ablations
  • PROCEDURE left atrial appendage occlusion

Study Locations (1)

Colorado

  • Valley View Hospital - Glenwood Springs

Trial Details

FieldValue
Enrollment Target 1,000 participants
Start Date 2016-03
Est. Completion 2030-03

What the Registry Record Tells You About NCT03428048

The ClinicalTrials.gov registry entry for NCT03428048 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 1,000 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,282-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (22% lower). The listed sponsor is Cardiovascular Innovation and Research Institute, which has 1 total studies on file at ClinicalTrials.gov.

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.

NCT03428048 reports 1 study location spanning 1 distinct geographic area - top geographies include Colorado.

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).

What interventions are being tested in trial NCT03428048?

The interventions under investigation include: Hybrid procedure (PROCEDURE), Endocardial ablations (PROCEDURE), left atrial appendage occlusion (PROCEDURE).

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.

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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