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Researchers are evaluating ziltivekimab, a new medicine not yet approved anywhere, to see if it can help people who were hospitalized due to a heart attack. The study aims to find out if ziltivekimab can reduce the development of heart disease and prevent future heart attacks or strokes. This is a Phase 3 clinical trial comparing ziltivekimab to a placebo in patients with acute myocardial infarction. Participants will receive an initial loading dose of ziltivekimab or matching placebo by injection under the skin as soon as possible after an invasive heart procedure, within 36 hours for STEMI or 48 hours for NSTEMI patients. After the loading dose, they will get monthly injections of the same study medicine for up to two years, in addition to their standard care. During the study, participants will be monitored for major cardiovascular events such as heart attack, stroke, and cardiovascular death. Researchers will also track other heart-related outcomes and safety measures over a period of up to 25 months. The study involves regular visits for injections, assessments, and laboratory tests to evaluate the medicines effects and patient health throughout the trial.

This research aims to compare atrioventricular junction ablation AVJA with continued optimal medication treatment for patients who have cardiac resynchronization therapy CRT and permanent or recurrent persistent atrial fibrillation AF with suboptimal heart rate control despite optimal medication. The study will randomly assign participants to one of two groups to evaluate which approach better manages heart function and quality of life over time. Participants will be randomly divided into two groups in equal numbers. One group will undergo AVJA, a procedure that disrupts the electrical connection between the upper and lower chambers of the heart, performed soon after randomization and repeated if necessary. The other group will continue with optimal medication treatment prescribed by their physician. CRT devices will be programmed uniformly with a base rate of 70 bpm and rate response functions activated unless not tolerated. Throughout the study, all participants will be regularly monitored at outpatient clinics. Researchers will assess heart failure events, quality of life using standardized questionnaires, medication doses, and heart function classification over a 3-year period. Secondary outcomes include mortality rates, heart failure hospitalizations, blood biomarker changes, and hospitalization days. Participants may switch from medication to AVJA if clinical deterioration occurs. The total study duration extends to 3 years with comprehensive follow-up to track these outcomes.

Researchers are evaluating the safety and effectiveness of the VDyne Transcatheter Tricuspid Valve Replacement System for treating tricuspid regurgitation, a heart valve disorder. The study aims to gather data to support the devices approval under Conformit Europenne CE marking. This clinical investigation is led by VDyne, Inc. and focuses on adults with severe tricuspid valve problems who are candidates for this treatment. Participants will receive treatment using the VDyne System, a device designed to replace the tricuspid valve via a minimally invasive procedure. The study includes one treatment group using this system. Key assessments will occur from baseline to one month after the procedure, with extended follow-up up to one year to track device-related major adverse events, valve function, quality of life, symptom status, and physical capacity. Throughout the study, participants will undergo imaging evaluations, functional tests like the 6-minute walk test, and quality of life questionnaires. Researchers will monitor safety and effectiveness at multiple time points, including 30 days, 3 months, 6 months, and one year after the procedure. The total duration of participation varies, with ongoing assessments to ensure comprehensive data collection and patient monitoring.

Researchers are evaluating the best timing for surgery in patients who have severe aortic regurgitation but do not yet show symptoms. This heart valve condition often affects younger men and can lead to serious heart changes if left untreated. The study compares early surgery guided by detailed heart imaging with the usual approach of monitoring patients and operating only when symptoms or advanced heart changes develop. The study involves two main groups one will receive early, state-of-the-art aortic valve surgery, including valve-sparing procedures or replacements, scheduled within three months after randomization. The other group will follow a watchful waiting strategy with regular check-ups and surgery only if clear indications arise during follow-up. All patients undergo advanced heart imaging, exercise tests, blood tests, and quality of life questionnaires at set intervals. Participants will have heart magnetic resonance imaging and echocardiography at the start and at 12 months, plus clinical exams and tests every six months. Researchers will monitor heart function, exercise capacity, blood markers, and quality of life. The main outcome is a composite safety and effectiveness measure 12 months after randomization. The study also tracks complications, hospitalizations, and survival over time, with careful follow-up planned through the study duration.