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Found 2 Actively Recruiting clinical trials
Actively Recruiting
Healthy Volunteer
Researchers are evaluating patient-reported outcomes for treatments of coronary artery disease and atrial fibrillation Afib at a center with low operator volume. The study aims to show the benefits of receiving care close to home and to assess symptom relief, function, and quality of life from the patients perspective. This research combines national registry data with patient questionnaires to improve quality of care and track outcomes over time. Participants receive routine procedures such as percutaneous coronary intervention PCI for coronary artery disease and surgical or endocardial ablation for Afib. The study collects data through disease-specific questionnaires like the Seattle Angina Questionnaire SAQ and the Atrial Fibrillation Effect on Quality-of-Life AFEQT Questionnaire, along with the Veterans Rand 12-Item Health Survey VR-12. Data is linked with national registries and monitored for quality assurance. Follow-up assessments occur at six months and annually for up to ten years. Participants complete baseline and follow-up questionnaires assessing symptoms, function, and quality of life. Researchers analyze changes in questionnaire scores and monitor hospital readmissions within 90 days after intervention. Safety and complications such as bleeding or vascular injury are recorded. The study involves continuous data validation, training, and statistical analysis to support quality improvement and value-based care over a long-term period.
Actively Recruiting
This research aims to gather real-world data on the safety and effectiveness of AtriCure devices used in different types of cardiac ablation procedures and left atrial appendage LAA management for patients with atrial fibrillation. The study will enroll up to 10,000 patients from multiple regions including the US, Canada, Europe, and Asia Pacific, without preselection bias. It is an observational registry to track outcomes over a long period. Participants will receive AtriCures open concomitant surgical ablation, hybrid convergent ablation, hybrid totally thoracoscopic ablation, or LAA exclusion procedures as part of their cardiac care. The study does not require additional visits or procedures beyond standard care. Patients are followed for up to ten years after their procedure according to the practices of their enrolling center. During the follow-up, researchers will monitor patients atrial fibrillation burden six months after ablation and record any adverse events related to the ablation procedure within one year. There are no additional study visits monitoring is based on routine clinical care. This allows for long-term data collection on treatment outcomes and safety in a real-world setting.