NCT03428048 · Cardiovascular Innovation and Research Institute
Cardiovascular Innovation & Research Institute 's NEXUS Registry, the Whole is Greater Than the Parts.
What this study is about
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.
View original scientific description
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
Ablation of the posterior aspect of the heart, an area thought to be the origin of chaotic arrhythmias in persistent Afib patients.
PROCEDURE
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
PROCEDURE
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 measures
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
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.
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
The VR 12 is a 12-item health survey, validated quality of life questionnaire- open source
Number of patients that experience a re-admit status post intervention
Time frame: Within 90 days 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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Where
- Glenwood Springs, Colorado
Collaborators
Valley View Hospital
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 1, 2020 · Source of record for eligibility and locations