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

NCT03428048 | Recruiting

• 1 other identifier: 2015_01
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease; Atrial Fibrillation (AF)

Outcome Measures

Primary Outcomes (3)

• Change from baseline in Atrial Fibrillation Effect on Quality -of-Life (AFEQT) questionnaire at designated follow-up intervals

  The AFEQT is a validated disease specific questionnaire used for assessing clinical disease impact on ADLs, emotional status, satisfaction with treatment and quality of life.

  Initial Analysis at baseline (administered pre-AF intervention) to follow-up intervals at 6 months and then annually thereafter up to 10 years

• Change from baseline in Veterans Rand (VR) 12

  The VR 12 is a 12-item health survey, validated quality of life questionnaire- open source

  Initial analysis at baseline (administered pre-AF intervention) to follow-up intervals at 6 months and annually thereafter up to 10 years

• Number of patients that experience a re-admit status post intervention

  The number of patients that are re-admitted with a Serious Adverse Event (SAE) or Adverse Event (AE) as a result of their index procedure

  Within 90 days post intervention

Secondary Outcomes (2)

• Number of patients that are in sinus rhythm post AF intervention

  Assessed 6 months post procedure and annually thereafter

• number of patients on anti-arrhythmic agents post intervention

  After 3 months post intervention /ablation known as blanking period and measured annually thereafter

Study Arms (1)

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.

Procedure: Hybrid procedure; Procedure: Endocardial ablations; Procedure: left atrial appendage occlusion

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.

Also known as: modified maze, epicardial ablation

Adults diagnosed with paroxysmal and persistent Afib

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

Also known as: radio frequency ablation, cryoablation, laser ablation, percutaneous ablation

Adults diagnosed with paroxysmal and persistent Afib

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

Also known as: left atrial clip, Watchman procedure, lariat procedure

Adults diagnosed with paroxysmal and persistent Afib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All comers outcomes registry

You may qualify if:

• Candidates will be included in the study only if all the following conditions are met:
• 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 may not qualify if:

• Candidates will be excluded from the study if any of the following conditions are present:
• Failure and / or inability and / or unwillingness to provide informed consent.
• Likely problems, in the judgement of the investigators, with maintaining follow-up.

Sponsors & Collaborators

• Cardiovascular Innovation and Research Institute: lead
• Valley View Hospital: collaborator

Study Sites (1)

Valley View Hospital

Glenwood Springs, Colorado, 81601, United States

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease; Atrial Fibrillation

Interventions

Radiofrequency Ablation; Cryosurgery; Laser Therapy; Catheter Ablation; Left Atrial Appendage Closure

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Arrhythmias, Cardiac; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative; Cardiac Catheterization; Catheterization; Investigative Techniques

Study Officials

• Frank A Laws, MD

  Valley View Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kim M Williams, MPH

CONTACT

970-384-7433; kim.williams@vvh.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2016
• First Posted: February 9, 2018
• Study Start: March 1, 2016
• Primary Completion: March 1, 2026
• Study Completion (Estimated): March 1, 2030
• Last Updated: June 1, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)