Cotignola

Researchers are evaluating the safety and effectiveness of pulmonary vein isolation using high power short duration radiofrequency energy in patients with paroxysmal or persistent atrial fibrillation. This prospective, multi-center study aims to understand how clinical and procedural factors relate to the recurrence of atrial fibrillation 12 months after ablation. At least 850 patients will be enrolled to provide reliable data on treatment outcomes and safety. Patients will undergo catheter ablation with approved mapping and ablation catheters. The procedure includes sedation or anesthesia, vascular access through femoral or subclavian veins, and creation of electrical isolation around the pulmonary veins using the QDot Micro catheter at specified power and duration settings. Mapping catheters will verify effective isolation and identify any vein reconnections for additional treatment. Post-procedure assessments include ECG and optional echocardiograms to check for complications. After the ablation, participants will have regular follow-ups at 3 months and detailed evaluations up to 12 months, including physical exams, ECGs, and 24-hour Holter monitoring to detect arrhythmia recurrence. The study will measure the relationship between clinical and procedural details and arrhythmia recurrence rates, with safety and efficacy monitored throughout. Freedom from atrial fibrillation symptoms during follow-up indicates successful treatment.

Researchers are conducting a prospective, observational, single-arm, multi-center registry to evaluate the outcomes and performance of surgical aortic valve replacement using the Avalus pericardial bioprosthesis. This study focuses on patients undergoing bioprosthetic aortic valve replacement with the Avalus valve, aiming to gather real-world clinical and hemodynamic data. The registry plans to include approximately 1000 patients from around 40 sites across Europe and possibly Canada, with broad inclusion criteria to reflect real-world use. Participants will receive the Avalus bioprosthetic valve during their surgical aortic valve replacement procedure. The study does not involve additional interventions beyond the standard surgical treatment, as it is an observational registry. The inclusion criteria are intentionally broad, excluding only patients under 18 years of age and those requiring salvage surgery. Data collection and evaluation will follow the Valve Academic Research Consortium-2 (VARC-2) criteria, with patient outcomes assessed up to one year after surgery. During the study, researchers will monitor participants for the composite outcome of all-cause mortality and disabling stroke within one year postoperatively. Patients will be informed of the risks and requirements of the registry and must provide informed consent. The study focuses on collecting detailed clinical and hemodynamic information to understand the safety and efficacy of the Avalus valve in a real-world patient population over the course of 12 months.

Researchers are evaluating the effectiveness of catheter ablation treatment in patients with Brugada Syndrome (BrS), a condition that can lead to dangerous heart rhythms. This study focuses on patients undergoing epicardial substrate homogenization, targeting abnormal fragmented prolonged low-frequency ventricular electrograms using a high-density, high-resolution mapping system with an equi-spaced electrode array. It aims to better characterize the arrhythmogenic substrate using advanced mapping techniques and to assess the long-term outcomes of this approach. The procedure involves ablating abnormal heart tissue detected by the equi-spaced electrode array and omnipolar electrograms (OTEGMs) during catheter ablation. This includes collecting detailed voltage and vector data to understand the disease mechanism. Patients undergo ablation using contact force catheters guided by high-density maps. The study builds on previous approaches and introduces a novel protocol to improve substrate definition and treatment precision. Participants will be followed up at 3, 6, and 12 months after the ablation procedure to measure the percentage of patients free from clinical ventricular arrhythmias. The study includes comprehensive data collection, including late potential and voltage maps, vector data, and speed maps. Safety and efficacy are monitored throughout the follow-up period, with particular attention to arrhythmia recurrence and long-term rhythm stability.

This study aims to understand why there may be differences between the measurements of the aortic valve taken before and during surgery. Specifically, it will compare the valve size suggested by a CT scan (Computed Tomography) with the size measured during the operation using surgical tools. This will help determine which method is more accurate for selecting the right valve size in patients undergoing SAVR (Surgical Aortic Valve Replacement ).

Researchers are evaluating the effects of using multiple arterial grafts (MAG) versus a single arterial graft (SAG) in women undergoing coronary artery bypass grafting (CABG). This international, multi-center randomized trial named ROMA:Women aims to determine whether MAG improves major heart and brain-related events and quality of life compared to SAG. The study includes 2,300 women to examine outcomes like death, stroke, heart attacks, repeat surgeries, and hospital stays, along with quality of life and mental and physical health symptoms in a subgroup of 500 participants. Important patient subgroups such as age, diabetes status, race, surgical techniques, and type of arterial grafts will also be analyzed. Participants will be randomly assigned to receive either single arterial grafting, where the left internal thoracic artery is connected to the heart's left anterior descending artery along with venous grafts, or multiple arterial grafting, where an additional arterial graft such as the right internal thoracic artery or radial artery is used for other coronary branches, plus other grafts as needed. The trial leverages existing infrastructure and continues enrollment with additional sites to reach its target sample size. Both treatment arms follow the same randomization, interventions, and follow-up protocols as the parent ROMA trial. During the study, researchers will monitor participants for at least 2.5 years after surgery to track major cardiac and cerebrovascular events and assess disease-specific and generic quality of life measures using questionnaires such as the Seattle Angina Questionnaire and PROMIS-29. The trial will collect data through clinical assessments and questionnaires to evaluate health outcomes and symptom changes. Safety and effectiveness will be closely followed to understand the impact of the two grafting methods in women undergoing CABG.

This research investigates how obesity impacts heart and metabolic health, focusing on the function of blood vessels and fat tissue. The study aims to detect early signs of vascular problems in people with obesity and understand how fat tissue communicates with blood vessels. Researchers are particularly interested in how significant weight loss after bariatric surgery affects these factors and overall cardiovascular risk. The study is based on the idea that obesity disrupts blood vessel function due to substances released by fat tissue and changes in gut bacteria, which may improve after surgery.

Researchers are evaluating 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. Heart failure is a serious condition with high rates of hospitalizations and healthcare costs. HeartInsight analyzes trends in seven physiological variables to provide early warnings of worsening heart failure, with a median lead time of 42 days. This study aims to assess how HeartInsight alerts are managed in routine clinical practice across multiple centers in Italy. About 100 patients will be enrolled across 14 centers and followed for 12 months. Participants have implanted devices with Home Monitoring and will be monitored remotely. When HeartInsight generates an alert, a standardized workflow guides clinical responses such as device adjustments, therapy optimization, unscheduled visits, or hospital admissions. The study collects data on alert frequency, clinical actions triggered, and patient use of the HeartInsight Patient App. Participants will provide informed consent and undergo standard remote monitoring and clinical visits. Data will be gathered through electronic case report forms, focusing on the proportion of alerts that lead to clinical actions, alert patterns, hospitalizations, and app usage. Safety and data quality will be monitored throughout. The study results aim to improve integration of predictive monitoring into patient care, potentially enhancing management and outcomes for heart failure patients.

Outflow tract ventricular arrhythmia (OTVA) is the most common type of ventricular arrhythmia, and catheter ablation (CA) is the primary treatment option for patients experiencing symptoms. Accurately identifying the origin site of OTVA is essential for effective catheter ablation, minimizing procedural risks, and enhancing treatment success. However, most studies that developed algorithms or scoring systems for distinguishing OTVA origins excluded participants with structural heart disease and those with paced rhythms from their study groups. A recent prospective evaluation of a hybrid score (HS) that integrates both clinical and ECG data to predict OTVA-SOO, including patients with cardiac implantable electronic devices and those with structural heart disease in our study. The presented study aimed to assess the effectiveness of the previously described hybrid algorithm in predicting OTVA-SOO in a patient population characterized by a wide basal QRS due to intraventricular conduction defects or paced rhythms. The Hybrid Score The Hybrid Score (HS), involves a sum of points based on clinical and ECG characteristics. Points are assigned as follows: one point each for being over 50 years old, male, and having arterial hypertension. ECG-based points are allocated according to QRS transition: 3 points for a transition in V1, 2 points for V2, 1 point for V3 if the R-wave in V3 is greater than 1 mV; 1 point is subtracted if V3 has an R-wave less than 1 mV, and further deductions or additions apply for transitions up to V6. A score ≤ 1 suggests an RVOT origin, whereas ≥ 2 suggests an LVOT origin. ECGs were recorded with a standard configuration at a 25 mm/s sweep speed. Premature Ventricular Contraction (PVC) Ablation Activation mapping of spontaneous OTVAs was conducted. The procedure aimed to abolish spontaneous OTVAs, with the site of ablation marking the site of origin (SOO). Collected data * Patient Information and Consent (procedure must be done within 60 days of consent) * Demographics (age, gender, etc.) * Vital signs (length, weight, etc.) * Medical history, including cardiovascular risk factors, cardiomyopathy and drugs * ECG data * Echocardiographic data (left ventricular ejection fraction and left ventricular end-diastolic diameter) * Procedure data (number of radiofrequency applications, site of effective ablation, total radiofrequency time, total fluoro time, points mapping, procedure time) * Adverse Events

Researchers are investigating the role of macrophages in coronary and peripheral artery diseases, including stable coronary artery disease, acute coronary syndromes, critical limb ischemia, and intermittent claudication. The study aims to evaluate and compare the presence and activation of macrophages within atherosclerotic lesions in these arteries. It also seeks to understand how these findings relate to the distribution of different circulating monocyte subpopulations. The study involves using Optical Coherence Tomography, a diagnostic test, to assess the number of macrophages infiltrating the affected artery walls. This evaluation occurs during procedures like peripheral angiography or coronary angiography. The study focuses on identifying macrophage presence and activation in the lesions of coronary and peripheral arteries. Participants will be monitored from enrollment until hospital discharge following their angiography procedures. Researchers will measure the presence and activation of macrophages in the artery lesions and correlate these findings with blood samples assessing monocyte subpopulations. This comprehensive approach aims to improve the understanding of macrophage involvement in artery disease progression and stability.

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.