Overland

Researchers are evaluating the safety and effectiveness of Tumor Treating Fields (TTFields) delivered by the NovoTTF-200T device combined with pembrolizumab and platinum-based chemotherapy for patients with metastatic non-small cell lung cancer (NSCLC) that has spread to other parts of the body. This Phase 3 randomized study aims to compare overall survival and progression-free survival between patients receiving this combination treatment and those receiving pembrolizumab with platinum-based chemotherapy alone. Additional analysis will examine outcomes based on lung cancer subtype and PD-L1 expression levels. The NovoTTF-200T is a portable, battery-operated device designed for continuous home use that emits electric fields to disrupt cancer cell division. Participants will receive this device alongside pembrolizumab, an immune checkpoint inhibitor, and standard platinum-based chemotherapy. The study will stratify patients by cancer histology, PD-L1 expression, and previous immunotherapy treatment. Treatments will be given according to the study protocol at approximately 130 sites globally. Participants will be monitored for up to six years to assess overall survival and progression-free survival using standardized criteria. The study includes regular evaluations of tumor response, safety, and other clinical outcomes. Participants must have good performance status and adequate organ function to join. The research team will collect data on cancer progression and survival to better understand the potential benefits and risks of adding TTFields to standard therapies for metastatic NSCLC.

Researchers are evaluating the safety and effectiveness of the CLAAS device compared to the commercially available WATCHMAN and Amulet left atrial appendage closure devices in patients with non-valvular atrial fibrillation who are at high risk of stroke or systemic embolism. The study aims to show that the CLAAS device performs at least as well as the other devices in preventing stroke and related complications. Eligible patients will be randomly assigned to receive either the CLAAS device or one of the other devices and will be monitored for five years following implantation. Participants will receive one of the three left atrial appendage closure devices: CLAAS, WATCHMAN, or Amulet. The devices are implanted to close off the left atrial appendage, reducing the risk of stroke. After the procedure, patients will be followed for up to five years to assess long-term safety and device performance. The study includes an initial period to observe procedure-related complications, bleeding events, and all-cause death within 12 months, as well as ischemic stroke and systemic embolism over 18 months. During the study, participants will undergo regular evaluations and follow-ups to monitor their health and device effectiveness. Researchers will track any complications related to the procedure, bleeding events, strokes, and overall survival. Safety will be closely monitored through clinical assessments and imaging as needed. Patient adherence to medication regimens and follow-up visits will also be checked throughout the study duration to ensure accurate and comprehensive data collection.

This research aims to evaluate treatment strategies for patients with heart failure with preserved ejection fraction (HFpEF) who also have atrial fibrillation (AF), a common co-condition in 43% of such patients. The trial addresses the challenge of managing HFpEF, a difficult syndrome with limited proven therapies. It investigates rhythm control approaches, which have not been systematically studied in this population, using a phase 4, randomized, open-label design to compare outcomes related to heart failure hospitalizations and cardiovascular death. The study is conducted in two phases. Phase 1 compares catheter ablation versus antiarrhythmic drug (AAD) therapy as initial rhythm control treatments in patients with AF and preserved systolic function who have had recent heart failure events. Phase 2 evaluates optimized rhythm control with or without the use of a wireless pulmonary artery pressure monitor to guide heart failure therapy. Patients in Phase 1 are randomized 1:1 to ablation or AAD, followed for at least six months after a three-month blanking period. Those completing Phase 1 enter Phase 2 and are randomized to either receive hemodynamic monitoring with a wireless sensor or standard heart failure care, again followed for at least six months. Participants will undergo assessments including monitoring for heart failure hospitalizations and cardiovascular mortality over 12 months. They will be evaluated for safety and efficacy of treatments, with data collected on heart failure events, rhythm control success, and hemodynamic parameters from the implanted sensor if applicable. The study involves multiple centers and includes clinical visits, lab tests, and imaging for heart function. This pilot trial's results will inform a larger pivotal study.