Castrovillari

Researchers are conducting an observational, prospective, multicenter study in Italian cardiology centers to evaluate how well patients with Heart Failure with Reduced Ejection Fraction (HFrEF) follow guideline-recommended treatments. The study also aims to assess the safety of these treatments, monitor treatment patterns in patients with acute heart failure, and observe treatment approaches in all chronic heart failure patients regardless of their ejection fraction levels. The study involves two phases of educational interventions and data collection. Initially, healthcare providers will receive education on guideline recommendations and treatment patterns, followed by 3 months of patient data collection or up to 30 consecutive patients with chronic or acute heart failure. After 6 months, treatment modifications and outcomes will be evaluated. Then, a second educational session will highlight gaps between guidelines and practice, followed by another 3 months of data collection. Patients will be followed for 12 months total, with ongoing monitoring of treatment changes and outcomes. Participants will be assessed at enrollment and during the follow-up periods through clinical evaluations and data collection on treatment adherence and safety. The main outcome measured is adherence to guideline-directed medical therapies over 6 months. The study includes evaluations at 6 and 12 months after enrollment, with close monitoring of treatment patterns and patient health status throughout the study duration.

Researchers are evaluating a program called EuroHeart, developed by the European Society of Cardiology (ESC), which aims to improve care for patients with common heart conditions like Acute Coronary Syndrome (ACS), heart failure, and atrial fibrillation. This observational, prospective, multicenter initiative collects standardized patient data continuously in real-world clinical settings to support ongoing quality improvement. The focus is on how well healthcare providers follow ESC quality indicators proven to improve patient outcomes, addressing gaps between research and everyday practice. The study specifically looks at the Italian implementation of EuroHeart, monitoring adherence to ESC quality indicators in clinical care. It does not involve experimental treatments but collects detailed data on the management of patients hospitalized with ACS, heart failure, or atrial fibrillation. Participants' care is tracked throughout their hospital stay and beyond, with no additional interventions imposed by the study. Participants will be followed for 12 months after enrollment. During this period, researchers will collect data on clinical events, treatment adherence, and patient status to evaluate how well ESC quality indicators are met, such as timely reperfusion for STEMI patients and appropriate medication prescriptions at discharge. This long-term follow-up supports efforts to enhance care quality and patient outcomes in cardiovascular diseases.

This research aims to assess the long-term outcomes, performance, and safety of the BIOMONITOR III implantable cardiac monitors (ICMs) and their possible successors in real-life clinical settings. The study also serves as a platform for additional scientific and regulatory investigations with minimal extra effort for both clinical sites and patients. It focuses on patients with conditions such as tachycardia, atrial fibrillation, syncope, bradycardia, and cryptogenic stroke. Participants will receive a BIOTRONIK Implantable Cardiac Monitor and use the CardioMessenger device as part of the BIOTRONIK Home Monitoring system. The study observes routine clinical care with these devices and may include submodules for further research. The timeline includes monitoring the time to diagnosis starting from the device insertion. Throughout the study, participants will be regularly monitored using the implanted device and home monitoring technology. Researchers will track outcomes related to device performance, safety, and the time it takes to reach relevant diagnoses. Participants provide informed consent and agree to use the home monitoring system during the study period, contributing to long-term data collection and safety assessment.

Researchers are evaluating the long-term reliability and performance of Medtronic cardiac rhythm products, including leads and devices used for pacing, sensing, or defibrillation. The study aims to analyze product survival probabilities to better understand their durability and performance over time. This research includes all Medtronic market-released leads and implantable devices for conditions such as arrhythmia, bradycardia, heart failure, and sinus tachycardia. Participants include those who have been implanted with at least one Medtronic market-released product or those who participated in qualifying Medtronic studies with complete implant and follow-up data. The study monitors these devices from the time of implant, tracking lead-related complications and device performance. If a patient exits the study, passes away, or the device is deactivated, the implant is no longer followed. During the study, researchers collect health information and monitor the devices to assess ongoing performance and complications. Follow-up is essential to confirm device status and ensure accurate data collection. The main outcome measured is lead-related complications for each lead model, with continuous observation from implant until termination due to patient or device status. Participation requires informed consent and authorization for access to health information as per institutional requirements.

This research aims to continuously evaluate and report on the safety and effectiveness of Medtronic products that are already available on the market. It addresses a wide range of conditions including cardiac rhythm disorders, neurological and cardiovascular disorders, digestive issues, respiratory therapy, and various surgical and diagnostic procedures. The registry supports patients, hospitals, clinicians, regulatory bodies, payers, and industry by simplifying the clinical monitoring process and enhancing performance assessment. Participants in this registry are those who have received or are planned to receive treatment with eligible Medtronic products. Enrollment can occur within a specific time window relative to starting therapy or retrospectively. The study does not involve specific interventions but focuses on the ongoing collection of data related to the products in use. During participation, individuals will be monitored periodically every 6 to 12 months depending on their therapy. Researchers will collect data to assess safety and effectiveness without additional procedures beyond standard care. Follow-up will continue as long as the therapy is ongoing, with the goal of providing long-term surveillance and valuable information to improve patient care and product performance.