Fidenza

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 patients who have experienced athero-thrombotic events such as coronary artery disease, cerebrovascular disease, or peripheral artery disease. The study aims to assess how well patients follow guideline recommendations, particularly focusing on improving cholesterol levels and other modifiable risk factors to reduce the chance of cardiovascular event recurrence. This observational and prospective study takes place across multiple cardiology centers in Italy to represent a broad patient population. The study includes several phases starting with an educational intervention to discuss guideline recommendations for secondary prevention. Following this, data is collected for three months or until 30 patients with documented cardiovascular conditions are enrolled, using a web-based case record form that identifies when guidelines are not followed and records reasons for non-adherence. After six months, primary and secondary outcomes are evaluated. A second educational intervention then shares findings from the first phase to highlight gaps in clinical practice, followed by another three-month data collection period and a further six-month outcome assessment. Finally, all patients are followed for 12 months to monitor longer-term results. Participants provide informed consent and are monitored through data collection forms that track adherence to guidelines and clinical outcomes. The main outcome measured is adherence to cholesterol management guidelines over six months. Additional assessments include adherence to recommendations for other cardiovascular risk factors. Throughout the study, researchers gather data to understand how guideline adherence affects patient health and to identify barriers to following best practices, with continuous follow-up over a year to evaluate sustained effects.

Researchers are evaluating the clinical characteristics and procedural efficacy and safety of different permanent cardiac pacing implantation approaches in patients over 18 years old who need a pacemaker or intracardiac defibrillator. The study focuses on various pacing methods including right chamber endocardial pacing, epicardial pacing, cardiac resynchronization therapy (CRT), conduction system pacing (CSP), and leadless pacing. The study aims to understand how these methods affect patient survival and quality of life, as well as the potential benefits of non-fluoroscopic anatomical and electrophysiological systems during implantation. Participants will receive permanent cardiac pacing devices according to European Society of Cardiology guidelines. The pacing types studied include conventional right ventricular pacing, conduction system pacing (such as His bundle and left bundle branch area pacing), CRT involving biventricular or left ventricular pacing, epicardial pacing, and leadless pacing. The study will observe the safety and effectiveness of these modalities at 30 days, 6 months, and 12 months, considering factors like stable electrical parameters, absence of hospitalizations, and device-related complications. During the study, researchers will collect clinical and procedural data from patients who have undergone device implantation at participating centers over a 10-year period, with an equal follow-up duration. Assessments will include monitoring device function, hospitalizations for heart failure, all-cause mortality, heart failure occurrence, and arrhythmias. Safety evaluations will track procedural complications, infections, and need for re-intervention. This comprehensive data collection aims to improve understanding of pacing methods and their impact on patient outcomes.

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.

Researchers are studying patients who receive transvenous pacemakers or implantable cardioverter-defibrillators (ICDs) with active fixation leads. The goal is to find the most reliable electrical measurement taken during lead implantation that can predict the best lead placement and long-term device performance. The study aims to see if the slew rate measured at implantation correlates with sensing at 12 months, and whether other electrical parameters recorded at the time of implantation relate to values measured a year later. Participants will receive active-fixation leads implanted in the heart, with site and pacing method chosen by the doctor. Electrical measurements including slew rate, current of injury, sensing, impedance, and capture threshold will be taken before and after lead fixation using the same pacing system analyzer. The current of injury is assessed immediately after helix deployment because it changes over time. Follow-up checks will happen at 1 and 12 months, either in person or remotely. During the study, participants will have device interrogations and electrical measurements recorded at implantation and during follow-up visits. The researchers will monitor lead position, electrical parameters, and any significant changes. The main outcome measured is the slew rate of active fixation leads at implantation, before helix deployment. The total follow-up period lasts 12 months from implantation to evaluate lead stability and device function over time.