Cotignola

Researchers are evaluating the safety and effectiveness of pulmonary vein isolation PVI using high power short duration HPSD radiofrequency energy in patients with paroxysmal or persistent atrial fibrillation AF. This prospective, multi-center study aims to understand the relationship between clinical and procedural factors and the success and safety of this ablation method, with a follow-up period of 12 months to monitor AF recurrence. Patients with paroxysmal or persistent AF will undergo catheter ablation using approved mapping systems and catheters. The procedure involves sedation or anesthesia, vascular access through femoral or subclavian veins, and placement of diagnostic and ablation catheters in the left atrium. Ablation is performed with a QDot Micro catheter delivering radiofrequency energy in specific modes to isolate pulmonary veins. Effectiveness of the isolation is confirmed during the procedure, and any reconnections are addressed. Post-procedure, an ECG and optional echocardiogram are done to check for complications. During the 12-month follow-up, patients will have regular assessments at 3 months including history, physical exams, ECG, and 24-hour Holter monitoring to detect arrhythmia recurrence. Additional follow-ups between 6 and 12 months help confirm freedom from arrhythmia if no symptoms are reported. Researchers will measure outcomes such as arrhythmia recurrence rates, procedural times, vein reconnection, anesthesia impact, pain perception, and fluoroscopy duration to evaluate the procedures overall safety and efficacy.

Researchers are studying Brugada Syndrome BrS, a heart condition that can cause dangerous irregular heartbeats, especially in patients who may not show symptoms at diagnosis. This study aims to evaluate the effectiveness of a catheter ablation procedure at medium to long-term follow-up in patients with BrS. The procedure targets abnormal heart signals detected using a high-density, high-resolution electrode array to better understand and treat the arrhythmogenic substrate associated with BrS. The study also investigates a new measurement called the dST-Tiso interval, which may predict the risk of arrhythmias in these patients. The treatment involves epicardial substrate homogenization by ablating abnormal fragmented prolonged low-frequency ventricular electrograms using a contact force catheter guided by detailed electrical mapping. This catheter ablation is performed in patients who have already had an implantable cardioverter defibrillator ICD and documented ventricular arrhythmias. The study collects data on heart electrical activity using advanced mapping tools and evaluates changes after the ablation procedure. The procedure aims to improve the definition of abnormal heart areas and may confirm links with specific ECG features. Participants will be monitored at 3, 6, and 12 months after the ablation procedure to assess freedom from ventricular arrhythmias. The study collects detailed electrical maps, vector data, and speed maps to help understand BrS mechanisms. Patients undergo regular follow-up visits where heart function and arrhythmia status are assessed. The study tracks long-term outcomes related to heart rhythm safety and effectiveness of the ablation approach. The total participation duration covers at least one year of follow-up after treatment.

Cardiovascular diseases are a leading cause of illness and death globally. This research aims to compare the effectiveness and feasibility of a cardiovascular prevention program delivered remotely via a digital app against traditional in-person care. The study focuses on patients at cardiovascular risk to help reduce events and slow disease progression. Participants will be randomly assigned to one of two groups one using remote management through a digital application to collect follow-up information, and another receiving traditional in-person follow-up at a hospital. The intervention involves providing recommendations to patients and monitoring their health through these different care pathways. During the study, participants will be followed for up to 24 months with regular assessments. Researchers will measure blood pressure at 12 months and track cigarette use, body weight, and daily steps over 24 months. The study monitors adherence to the assigned care model and evaluates health outcomes at scheduled follow-up visits.

Researchers are studying the differences between aortic valve measurements taken before surgery using CT scans and those taken during surgery with surgical tools. This study focuses on patients with severe aortic stenosis who are undergoing Surgical Aortic Valve Replacement SAVR with a bioprosthetic valve. The goal is to understand which measurement method is more accurate for selecting the right valve size. All participants will have a pre-operative CT scan of the aortic root following a specific protocol that uses retrospective electrocardiogram gating to capture heart motion details. The measurements from this CT scan will be used to estimate the appropriate size for two types of theoretical Transcatheter Aortic Valve Replacement TAVR prostheses. During surgery, the valve size will also be measured directly using surgical tools. Participants will be asked to comply with study procedures and return for follow-up visits. Researchers will compare the pre-operative CT measurements with intraoperative measurements to evaluate the accuracy of each method for aortic valve sizing. The main outcome measured is the aortic valve annular sizing before surgery. The study is expected to be completed by the end of 2026.

Researchers are evaluating the outcomes of different coronary artery bypass grafting techniques in women with heart disease. The trial compares multiple arterial grafting MAG to single arterial grafting SAG to see if using multiple arterial grafts improves major heart and brain-related events and quality of life. This international randomized clinical trial includes 2,300 women to assess differences in survival, stroke, heart attacks, repeat surgeries, and hospital readmissions, as well as physical and mental health. Participants will be randomly assigned to one of two groups. One group receives a single arterial graft using the left internal thoracic artery plus additional venous grafts. The other group receives multiple arterial grafts, including the left internal thoracic artery and at least one other arterial graft such as the right internal thoracic artery or radial artery, with possible additional arterial grafts. The study uses the infrastructure of an existing trial and follows patients for at least 2.5 years after surgery. During the study, researchers collect data on major adverse cardiac and cerebrovascular events, along with quality of life measured by general and disease-specific questionnaires. Physical and mental health symptoms are also assessed. Follow-up includes tracking deaths, strokes, heart attacks, repeat procedures, and hospital stays. The trial aims to provide detailed information on outcomes and quality of life in women undergoing coronary bypass surgery over a long-term period.

This research investigates how obesity impacts heart and metabolic health, focusing on blood vessels and fat tissue functions. It aims to detect early signs of vascular problems and understand the communication between fat tissue and blood vessels. The study explores how bariatric surgery-induced weight loss may improve these functions and reduce cardiovascular risk over time. Participants undergo bariatric surgery, either mini-gastric bypass or sleeve gastrectomy. Before surgery, blood, urine, stool, and fat tissue samples are collected, along with a cardiology examination. These assessments continue at 6 and 12 months after surgery to monitor changes in vascular tissue, adipose tissue, inflammation, and related blood markers. During the study, participants attend follow-up visits for sample collection and health evaluations. Researchers measure vascular and adipose tissue changes from baseline to 12 months, focusing on blood vessel function and inflammatory substances. This ongoing monitoring aims to track recovery of endothelial health and overall cardiovascular risk after significant weight loss.

This research investigates the real-world use of the HeartInsight algorithm, designed to predict acute heart failure events in patients with implanted Biotronik ICD or CRT-D devices that have atrial sensing and Home Monitoring capabilities. Heart failure is a serious condition with high rates of hospitalizations and healthcare costs. The HeartInsight algorithm, validated in previous studies, monitors trends in seven physiological parameters to provide early warnings about worsening heart failure, aiming to improve patient management by alerting healthcare providers well in advance. Patients enrolled in this prospective, multicenter observational registry will be followed for 12 months across approximately 14 centers in Italy. The study does not require additional diagnostic tests beyond standard care. When HeartInsight issues an alert, a standardized workflow guides clinical responses such as device adjustments, therapy changes, or extra visits. Patients may also choose to use the HeartInsight Patient App to assist in monitoring. The study collects data on how often alerts occur, the clinical actions taken, patient interviews, and hospitalizations. Participants will have their device data remotely monitored and attend regular clinical visits as part of routine care. Researchers will track the proportion of alerts that lead to clinical actions and measure secondary outcomes like alert frequency, duration of alert periods, patient interviews, hospitalizations, and app usage. Data are collected securely via electronic forms and monitored for quality. The study aims to provide insights into integrating predictive monitoring tools into everyday practice to potentially enhance heart failure care over a 12-month period.

This research aims to evaluate a hybrid scoring system designed to predict the origin site of outflow tract ventricular arrhythmias OTVA in patients who have wide basal QRS complexes due to intraventricular conduction defects or paced rhythms. Accurately determining the origin of OTVA is important for guiding catheter ablation, which is the main treatment for symptomatic OTVA, helping to reduce risks and improve success. Previous studies excluded patients with structural heart disease or paced rhythms, but this study includes them to better assess the hybrid scores effectiveness. The study uses a hybrid score combining clinical data age over 50, male sex, presence of arterial hypertension and ECG features related to QRS transition points to distinguish between right ventricular outflow tract RVOT and left ventricular outflow tract LVOT origins. ECGs are recorded with standard settings, and activation mapping during spontaneous OTVA is performed to identify the ablation site. Patients are grouped based on whether their arrhythmia originates in the RVOT or LVOT. Participants provide consent and submit demographic, medical history, ECG, and echocardiographic data. The catheter ablation procedure is monitored collecting data on radiofrequency applications, procedure times, and mapping points. The main outcome measured is the hybrid scores predictive performance at the time of the procedure, with safety assessed one month afterward. Adverse events are tracked, and comprehensive clinical and procedural information is gathered to support the evaluation.

Researchers are investigating the role of macrophages in the instability of coronary artery lesions and how circulating monocytes relate to these macrophages. This study focuses on comparing macrophage presence and activation in both coronary and peripheral artery disease, aiming to understand their distribution in relation to monocyte subpopulations. The conditions studied include stable coronary artery disease, acute coronary syndromes, intermittent claudication, and critical limb ischemia. Participants will undergo Optical Coherence Tomography assessment, a diagnostic test that evaluates the number of infiltrating macrophages within atherosclerotic lesions. The study includes groups with different artery diseases such as stable coronary artery disease, acute coronary syndrome, intermittent claudication, and critical limb ischemia. This is a non-randomized interventional study without masking or placebo control. During the study, researchers will monitor the presence and activation of macrophages in coronary and peripheral lesions from enrollment until hospital discharge after angiography procedures. The main outcome measured is macrophage presence and activation in these lesions. Participants will be observed closely during this period to correlate these findings with circulating monocyte subpopulations. The total duration of participation spans from enrollment through the hospital stay following angiography.

Researchers are evaluating the long-term performance and reliability of Medtronics market-released cardiac rhythm therapy products, including leads and devices used for pacing, sensing, or defibrillation. This observational study aims to analyze how well these cardiac devices function over time by measuring survival probabilities and tracking device-related complications. The study applies to patients with conditions such as arrhythmia, bradycardia, heart failure, and sinus tachycardia. The study includes all Medtronic market-released cardiac leads and implantable devices such as pacemakers IPG, implantable cardioverter defibrillators ICD, and cardiac resynchronization therapy CRT devices. Participants either have a new implant or are within 30 days post-implantation. Data from prior qualifying Medtronic studies with complete follow-up may also be included. The study continuously monitors these products from the time of implant until the lead is no longer in use due to patient exit, death, or device deactivation. Participants provide consent for data access and use, and their health information is tracked over the long term. Researchers evaluate lead-related complications and product survival throughout the study period, which began in 1983 and is ongoing until 2040. The study does not involve additional treatments but collects follow-up data to assess device performance and safety over time.