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Researchers are investigating whether ziltivekimab can treat people living with heart failure and inflammation. The study compares ziltivekimab, a new medicine not yet approved anywhere, to a placebo, an inactive substance that looks like the medicine but contains no active drug. Participants have an equal chance of receiving either treatment. The study is expected to last up to one year and four months and focuses on people with heart failure who also have systemic inflammation. Participants will receive either ziltivekimab or placebo by monthly injections under the skin. The doses are given once a month throughout the study period. The study lasts for 12 months of treatment following randomization, during which the effects of the medicine compared to placebo will be closely monitored. During the study, participants will undergo various assessments including a heart failure questionnaire called the Kansas City Cardiomyopathy Questionnaire (KCCQ) to measure symptoms and physical function over the 12 months. Other evaluations may include walking tests and heart function tests. Safety and health will be monitored regularly to understand how participants respond to the treatments and to track any side effects or changes in heart failure symptoms.

Researchers are evaluating whether ziltivekimab can help people who were hospitalized due to a heart attack by potentially reducing the development of heart disease and preventing new heart attacks or strokes. This Phase 3 study compares ziltivekimab with a placebo, which is a dummy medicine that has no effect on the body. Both treatments are given by chance, with equal likelihood for participants to receive either ziltivekimab or placebo. Participants will inject the study medicine once a month under the skin in the stomach, thigh, or upper arm. Ziltivekimab is given as an initial loading dose followed by monthly maintenance doses. The placebo group receives a matching injection schedule. The study duration is about two years. During the study, researchers will monitor participants for the time until the first serious heart-related event, including cardiovascular death, non-fatal heart attack, or non-fatal stroke. Participants will be closely observed from the start of randomization up to 25 months. The study includes regular follow-ups to assess safety and effectiveness of the treatments throughout this period.

Researchers are comparing atrioventricular junction ablation (AVJA) with continued optimal medical rate control in patients who have cardiac resynchronization therapy (CRT) and permanent atrial fibrillation (AF) but still experience suboptimal heart rate control despite medication. The study focuses on patients with recurrent or persistent AF who have been treated with CRT devices for more than six months and are on optimized heart failure and rate control medications. The goal is to evaluate whether AVJA improves heart function and quality of life compared to medication alone. Participants will be randomly assigned to either receive AVJA or continue with the best possible medical treatment. AVJA involves a procedure to disrupt the electrical connection between the upper and lower chambers of the heart, aiming to improve heart rhythm control. The CRT device will be programmed to a base rate of 70 beats per minute, and all patients will be regularly monitored. Cross-over to AVJA may occur at any time during the study if there is clinical deterioration or suspected inadequate biventricular pacing. Throughout the three-year follow-up, participants will have regular outpatient visits where heart failure events, quality of life, heart function, medication doses, and heart failure classification will be assessed. The study will use questionnaires such as the Minnesota Living with Heart Failure Questionnaire to measure quality of life. Researchers will closely monitor patient status and treatment effects to understand the benefits and risks of AVJA versus medical therapy in this group.

Researchers are evaluating the safety and effectiveness of the VDyne Transcatheter Tricuspid Valve Replacement System in adults with severe tricuspid valve regurgitation. This study aims to gather data to support the European CE Mark approval for the VDyne System. Participants must have significant tricuspid valve disease and be suitable candidates for this treatment as determined by a Heart Team and specialized committees. The investigational treatment involves implanting the VDyne Transcatheter Tricuspid Valve Replacement System. The study does not specify different treatment groups or dosing schedules, focusing on the device's use during a single procedure. Suitability for the device is confirmed before the procedure through clinical and imaging assessments. Participants will be monitored for safety and treatment outcomes up to one month after the procedure. Researchers will assess major adverse events related to the device or procedure, changes in tricuspid valve leakage, quality of life, functional capacity measured by a 6-minute walk test, and symptom status using the NYHA classification. Follow-up visits and tests will track these outcomes and overall patient health during the study period.

This research investigates the best timing for surgery in patients with severe aortic regurgitation who do not yet show symptoms. The study focuses on comparing early surgical treatment guided by cardiac magnetic resonance (CMR) assessment with the usual approach based on current guidelines. Aortic regurgitation causes the heart's left ventricle to overload, and severe untreated cases can lead to serious heart damage. The study aims to find out if earlier surgery can improve heart function and reduce complications compared to waiting until symptoms or severe heart changes appear. Participants will be divided into groups based on CMR measurements. Those meeting certain criteria for severe aortic regurgitation will be randomized to either have surgery within three months or follow a watchful waiting strategy according to guidelines. The surgical options include advanced procedures such as valve-sparing surgery or the Ross procedure, performed by experienced surgeons. Those not meeting the CMR criteria will be followed in a registry. Regular assessments will occur, including imaging, blood tests, and exercise tests. Throughout the study, participants will undergo comprehensive evaluations including cardiac magnetic resonance imaging, advanced echocardiography, ECG, blood sampling, and exercise stress testing at the start and during follow-up visits every six months. Quality of life will be assessed through questionnaires. The main outcome measured is a combination of safety and effectiveness at 12 months after randomization, ensuring that surgery timing is both safe and beneficial. Participants will be closely monitored for changes in heart function and overall health during the study.

Paraprosthetic cardiac valve leaks are a complication that can occur after surgical or percutaneous heart valve replacement, potentially causing heart failure or serious breakdown of red blood cells. Researchers are studying the outcomes of a less invasive treatment option called percutaneous closure for these leaks, which has been developed for patients who face high risks with surgery. This research aims to assess both the technical success and clinical results of this procedure, as well as its impact on patients' quality of life, which is not yet well understood. The treatment involves placing an occluder or vascular plug device into the leak through a minimally invasive approach, usually accessing the heart via blood vessels in the leg or through the chest wall. Different types of devices may be used, chosen by the treating physician, and their effectiveness is checked using ultrasound imaging before final placement. This procedure is being evaluated in a European registry that collects data on its success, complications, and patient outcomes. Participants will be monitored over time to assess clinical success, which includes survival, hospitalizations for heart failure, need for blood transfusions, and further valve interventions. Quality of life will be measured before treatment and at several points afterward using a standard questionnaire. Additional evaluations include heart function tests and blood markers related to hemolysis and heart failure. The overall follow-up spans up to two years to capture both short- and long-term results of the procedure.

Researchers are evaluating the use of mixed reality (MR) technology, specifically Hololens 2.0 combined with specialized software for three-dimensional DICOM image visualization, during MitraClip implantation procedures. This study focuses on patients with mitral valve regurgitation and aims to explore how MR might improve precision and spatial awareness in this interventional cardiology procedure. The work serves as a preliminary case series that lays the groundwork for a larger pilot study. The intervention involves performing MitraClip implantation, a procedure designed to catch and reduce leaks in the mitral valve. The study compares four MitraClip implantations using MR technology to assess procedural efficiency and radiation exposure. The MitraClip device is tested during the procedure to confirm reduction of the valve leak. Participants will be monitored through various assessments including operator stress indicators measured before, during, and immediately after the procedure, both physiologically and subjectively. These evaluations capture real-time operator stress and subjective feedback right after the procedure. The study also tracks procedural details and radiation exposure to understand the impact of MR technology on the implantation process.