Visos

Bronchiectasis is a chronic lung condition where parts of the bronchial tubes become permanently widened, leading to mucus buildup, infections, and ongoing inflammation. Managing this disease often includes respiratory physiotherapy to help clear mucus. However, accessing this therapy regularly can be difficult due to time, location, and availability of trained professionals. Researchers are evaluating the long-term use of the SIMEOX device, which uses brief air pressure pulses to help loosen and move mucus, combined with remote physiotherapy, to improve the quality of life and reduce lung flare-ups in adults with non-cystic fibrosis bronchiectasis. The study compares two groups: one using the SIMEOX device daily at home along with remote physiotherapy sessions, and a control group receiving enhanced standard care plus remote physiotherapy. The remote physiotherapy is delivered monthly for the first three months and then every three months afterward. The study lasts on average 24 months, allowing assessment of the device's effects over the mid and long term. Participants will be monitored through quality of life questionnaires and tracking of pulmonary exacerbations during the study. Evaluations include respiratory assessments and ensuring participants can use the device and follow procedures. The main outcomes measured are changes in respiratory quality of life after six months and the annual rate of lung exacerbations over the full study period. Safety and treatment adherence will also be continuously reviewed throughout participation.

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.

This research aims to continuously evaluate and report on the safety and effectiveness of Medtronic products that are already available on the market. It addresses a wide range of conditions including cardiac rhythm disorders, neurological and cardiovascular disorders, digestive issues, respiratory therapy, and various surgical and diagnostic procedures. The registry supports patients, hospitals, clinicians, regulatory bodies, payers, and industry by simplifying the clinical monitoring process and enhancing performance assessment. Participants in this registry are those who have received or are planned to receive treatment with eligible Medtronic products. Enrollment can occur within a specific time window relative to starting therapy or retrospectively. The study does not involve specific interventions but focuses on the ongoing collection of data related to the products in use. During participation, individuals will be monitored periodically every 6 to 12 months depending on their therapy. Researchers will collect data to assess safety and effectiveness without additional procedures beyond standard care. Follow-up will continue as long as the therapy is ongoing, with the goal of providing long-term surveillance and valuable information to improve patient care and product performance.

Researchers are evaluating the effectiveness of nucresiran compared to a placebo in reducing death from any cause and cardiovascular events in patients with transthyretin amyloidosis that affects the heart. The study also aims to assess how nucresiran impacts additional cardiovascular events, mortality, and patient-reported health status and quality of life. This is a Phase 3, global, randomized, double-blind, placebo-controlled trial focusing on this serious heart condition. Participants will receive either nucresiran 300 mg or a placebo (sterile normal saline) via subcutaneous injection every six months. The study treatment period is expected to last about 32 months, with a maximum duration of up to 5 years. Both groups will be monitored closely throughout this time, and patients may continue other approved therapies for transthyretin amyloidosis and heart failure as recommended by their doctors. During the study, participants will undergo regular assessments to track all-cause mortality and recurrent cardiovascular events, including hospitalizations and urgent visits for heart failure. Other evaluations will include patient-reported health outcomes and quality of life measurements. Researchers will monitor safety and treatment effects over the full study period, with a focus on how well nucresiran may improve health and reduce cardiovascular complications in this patient population.

Researchers are evaluating whether the drug zilebesiran can reduce the risk of major cardiovascular events such as cardiovascular death, nonfatal heart attacks, strokes, or heart failure in adults who have hypertension that is not well controlled and who either have established cardiovascular disease or are at high risk for it. This Phase 3 global study is designed to continue until enough cardiovascular events have occurred to assess the treatment's effect. Participants will be randomly assigned to receive either zilebesiran or a placebo, both given as injections under the skin (subcutaneous administration). All participants will continue with their standard care, which includes treatment with at least two antihypertensive medications, one of which must be a diuretic such as a thiazide or loop diuretic. The study is double-blind, so neither participants nor researchers know who is receiving the active drug or placebo. During the study, participants will be closely monitored for cardiovascular events including heart attacks, strokes, heart failure hospitalizations, and cardiovascular deaths over approximately five years. Researchers will collect data on these events to determine the time until the first occurrence of any of these outcomes. Safety assessments and standard clinical evaluations will also be performed throughout the study period to ensure participant well-being.