Glenwood Springs

Researchers are studying patients with coronary artery disease and atrial fibrillation (Afib) to evaluate the effects of percutaneous coronary intervention (PCI) and surgical or endocardial ablation treatments performed by low-volume operators. The goal is to understand how receiving care close to home at centers with fewer procedures impacts patients' symptoms, function, and quality of life. This study uses patient-reported outcomes combined with data from the National Cardiovascular Data Registry (NCDR) to assess the benefits of these treatments from the patients' perspectives and to improve quality of care. Participants will undergo routine procedures such as PCI for coronary artery disease and various ablation techniques for Afib, including hybrid procedures targeting the heart's posterior, endocardial ablations isolating pulmonary veins, and left atrial appendage occlusion to reduce stroke risk. Patients complete disease-specific questionnaires like the Seattle Angina Questionnaire (SAQ) for coronary disease and the Atrial Fibrillation Effect on Quality-of-Life (AFEQT) questionnaire for Afib, along with the Veterans Rand 12-Item Health Survey (VR-12), at baseline and follow-up intervals. The study will continue monitoring these outcomes annually for up to 10 years. During the study, patients complete questionnaires before and after their interventions, with follow-ups at six months and yearly thereafter. Researchers collect clinical data from the NCDR registries and perform quality assurance through ongoing staff training, data audits, and standardized procedures. Outcome measures include changes in quality of life and symptom scores over time, as well as rates of hospital readmission within 90 days post-intervention. Efforts are made to maintain follow-up and manage missing data, ensuring thorough long-term assessment of treatment effectiveness and patient well-being.

This research aims to capture real-world safety and effectiveness data on AtriCure devices used for open concomitant, hybrid, and totally thoracoscopic ablation procedures, as well as left atrial appendage (LAA) management, to treat atrial fibrillation. The study involves up to 10,000 patients across approximately 250 sites worldwide, including regions such as the US, Canada, Europe, and Asia Pacific. Patients eligible for this registry have been scheduled for or have undergone a cardiac ablation procedure using these devices. Participants will receive one of several AtriCure device-based procedures designed to manage atrial fibrillation, including open concomitant surgical ablation, hybrid convergent ablation, hybrid totally thoracoscopic ablation, or LAA exclusion procedures. These procedures are performed according to standard medical practice at each enrolling center, and the study does not require any additional visits or interventions beyond usual care. Patients will be followed for up to ten years after their procedure to monitor outcomes. Researchers will assess patients' atrial fibrillation burden six months post-ablation and track adverse events related to the ablation procedure over one year. There are no extra study visits; data collection aligns with standard clinical follow-up, focusing on long-term safety and effectiveness of the devices used in these ablation procedures.