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

Part of paid clinical trials in Glenwood Springs, Colorado.

Sponsor
Cardiovascular Innovation and Research Institute
Study ID
NCT03428048
Status
Recruiting
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Conditions

  • Atrial Fibrillation (AF)
  • Coronary Artery Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Hybrid procedure — PROCEDURE
    Ablation of the posterior aspect of the heart, an area thought to be the origin of chaotic arrhythmias in persistent Afib patients.
  • Endocardial ablations — PROCEDURE
    ablations occurring inside the heart isolating the pulmonary veins - blocking energy from creating irregular or chaotic heart beats with use of a catheter
  • left atrial appendage occlusion — PROCEDURE
    A procedure to isolate the left atrial appendage of the heart. this anatomic body is the origin of clot formation which can lead to stroke. the clot formation as a result of Afib

Study Details

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.

Key Dates

Start date
Mar 31, 2016
Status verified
May 2020
Primary completion
Mar 31, 2026
Completion
Mar 31, 2030

Study Design

Enrollment
1,000 participants (estimated)

Arms

  • Arm: Adults diagnosed with paroxysmal and persistent Afib
    Adults diagnosed with paroxysmal and persistent Afib who are identified as candidates for an intervention either surgical (epicardial) known as the hybrid approach or an endocardial ablation with either laser, radio frequency or cryoablation energy source.

Primary Outcome Measure

Change from baseline in Atrial Fibrillation Effect on Quality -of-Life (AFEQT) questionnaire at designated follow-up intervals [ Time Frame: Initial Analysis at baseline (administered pre-AF intervention) to follow-up intervals at 6 months and then annually thereafter up to 10 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Valley View HospitalGlenwood SpringsColorado81601
Kim M Williams, MPH
[email protected]
970-384-7433
Sean O'Flinn
sean.o'[email protected]
970-384-7436
Frank A Laws, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Valley View Hospital· Glenwood Springs, CO

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