What this study is
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.
What's being tested
- Hybrid procedure
Intervention · 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
Intervention · 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
Intervention · 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
- Official title
- 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.
- Sponsor
- Cardiovascular Innovation and Research Institute
- Conditions
- Coronary Artery Disease · Atrial Fibrillation (AF)
- Enrolling
- 1,000 people
- Starts
- 2016-03
- Est. completion
- 2030-03
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers AcceptedYou may qualify if
- 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.
You can't join if
- Failure and / or inability and / or unwillingness to provide informed consent.
- Likely problems, in the judgement of the investigators, with maintaining follow-up.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openValley View Hospital
Glenwood Springs, Colorado, United States
- Kim M Williams, MPH · Contact970-384-7433kim.williams@vvh.org
- Sean O'Flinn · Contact970-384-7436sean.o'flinn@vvh.org
- Frank A Laws, MD · Principal investigator
Recruiting
Study team
Sponsor
Cardiovascular Innovation and Research Institute
Study ID 2015_01
Principal investigator
Frank A Laws, MD
Valley View Hospital
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.