Recruiting

Observational Study

Sponsor:

Cardiovascular Innovation and Research Institute

Code:

NCT03428048

Conditions

Coronary Artery Disease

Atrial Fibrillation (AF)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Hybrid procedure

Endocardial ablations

left atrial appendage occlusion

Study Details

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)

Study ID

NCT03428048

Start date

Mar, 2016

Status verified date

May, 2020

Completion date

Mar, 2030

Anticipated

Primary completion date

Mar, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

Candidates will be included in the study only if all the following conditions are met:

1. Age >18 years
2. The subject has been informed of the nature of the study, agrees to its provisions, is able to comprehend, and has provided informed consent.
3. The subject is available for follow-up.
4. The subject has a diagnosis of coronary artery disease or Afib.

Exclusion Criteria:

Candidates will be excluded from the study if any of the following conditions are present:

1. Failure and / or inability and / or unwillingness to provide informed consent.
2. Likely problems, in the judgement of the investigators, with maintaining follow-up.

Study Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Hybrid 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

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

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

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 ]
  • Change from baseline in Veterans Rand (VR) 12 [ Time Frame: 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 [ Time Frame: Within 90 days post intervention ]

Central Contacts and Locations

Central contacts

Locations

Valley View Hospital

Recruiting

Glenwood Springs, Colorado, United States, 81601

Contacts

Principal Investigator:

Frank A Laws, MD

More Information

Sponsor

Cardiovascular Innovation and Research Institute

Last update posted

Jun 1, 2020

Last verified

May, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Cardiovascular Innovation and Research Institute on 2020-06-01.