Ustron

Researchers are evaluating the effect of a triple therapy inhaler called BGF MDI containing budesonide, glycopyrronium, and formoterol fumarate compared with a dual therapy inhaler called GFF MDI containing glycopyrronium and formoterol fumarate in people with Chronic Obstructive Pulmonary Disease (COPD) who have a higher risk of heart and lung problems. This Phase III randomized, double-blind, parallel group study takes place at multiple centers and focuses on cardiopulmonary outcomes in these patients. Participants receive either the BGF MDI 320/14.4/9.6 micrograms twice daily or the GFF MDI 14.4/9.6 micrograms twice daily. The treatments are inhaled using metered dose inhalers. The study compares these two therapies over time to see how they affect the time until the first severe heart or lung event occurs. The study design ensures that neither participants nor researchers know which treatment is given to reduce bias. During the study, participants will have regular visits to the study site or virtual visits to complete assessments. Researchers will monitor lung function, symptoms, and blood tests, including blood eosinophil counts and COPD assessment test scores. The main outcome measured is the time to the first severe cardiac or COPD event, with follow-up lasting up to three years. Safety and adherence to treatment will also be closely observed throughout the study period.

Atrial Septal Defect (ASD) is a type of congenital heart defect that can potentially be treated without open-heart surgery. Traditionally, ASD closure has been done surgically, but percutaneous transcatheter occluder devices offer a less invasive alternative. This research evaluates the Lifetech Cera™ ASD Occluder, a device designed for non-surgical closure of ASD, aiming to collect real-world clinical data and confirm its long-term safety and performance while identifying any unknown side effects. The study is a multi-center, single-arm post-market clinical follow-up involving patients who have already received the Lifetech Cera™ ASD Occluder device between January 1, 2020, and December 31, 2023. About 139 participants will be enrolled and followed for a total of 24 months after implantation. This follow-up will provide important information on the procedural success and ongoing safety of the device. Participants will be monitored through scheduled follow-up visits to assess the device's performance and any complications. Researchers will collect clinical data, including procedural success measured at 6 months post-implantation. The total study duration includes an enrollment period of approximately one year and a two-year follow-up post-implantation, ensuring long-term safety monitoring and data collection.

Researchers are exploring the best treatment for patients with multivessel coronary artery disease or left main narrowing who experience symptoms of acute ischemia without ST-segment elevation. This study compares two revascularization strategies: percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG). Existing guidelines recommend CABG, but recent studies suggest PCI may offer similar long-term outcomes with fewer immediate risks. The trial aims to test whether PCI is not worse than CABG in terms of major cardiac and cerebral events like death, heart attack, or stroke within one year after treatment. Participants will be randomly assigned to either PCI or CABG. PCI involves using modern drug-eluting stents along with assessments like fractional flow reserve and intravascular imaging to optimize the procedure. CABG will be performed using standard surgical techniques, including the use of the internal mammary artery. Both treatments aim to achieve complete revascularization. The study includes patients with a Syntax Score below 33, indicating moderate complexity of coronary disease. In centers without surgical facilities, heart team consultations will occur via videoconference. During the study, patients will be closely monitored with follow-up visits that include cardiac ultrasound and stress tests. Researchers will assess outcomes like death, heart attacks, strokes, revascularization needs, heart function, bleeding events, new heart rhythm problems, heart failure, hospital readmissions, quality of life, and cost effectiveness. Patients will also receive standard secondary prevention care, including cardiac rehabilitation. The total follow-up period includes one year after the procedure to evaluate major adverse cardiac and cerebral events.

Researchers are evaluating whether catheter-based endovascular left atrial appendage occlusion can prevent ischemic stroke or systemic embolism in people with atrial fibrillation who remain at high risk of stroke despite ongoing treatment with oral anticoagulants. This multicenter, prospective, open-label randomized trial uses blinded assessment of outcomes to provide clear results. The study focuses on participants with persistent, permanent, or certain types of paroxysmal atrial fibrillation and elevated stroke risk. Participants will receive treatment using the WATCHMAN device to perform left atrial appendage occlusion through a catheter-based approach. This device-based intervention is compared to usual care with oral anticoagulants, which participants must have been taking for at least 90 days before enrollment. The study period is event-driven and will continue until 265 primary endpoint events of ischemic stroke or systemic embolism occur, with an estimated average follow-up of about 4 years. During the study, participants will be closely monitored for stroke or embolism events as the primary outcomes. The trial assesses the safety and efficacy of the procedure in addition to ongoing anticoagulant therapy. Participants must be able to provide informed consent and are followed throughout the study duration to evaluate these outcomes.