Spring Hill

Researchers are evaluating the effects of the ABC Bicuspid Sizing Algorithm on clinical outcomes for patients with bicuspid aortic stenosis undergoing transcatheter aortic valve replacement (TAVR) using the Sapien 3 valve. This study aims to determine whether the algorithm improves technical success immediately after the procedure and device success 30 days post-procedure. It is a multi-center, international, prospective cohort study enrolling about 290 patients eligible for TAVR or surgical aortic valve replacement (SAVR). The ABC Bicuspid Sizing Algorithm helps doctors assess CT scans to guide decisions on whether patients should receive TAVR or SAVR and to select the appropriate valve size for TAVR patients. In some cases, gated CT scans or artificial intelligence-based simulations are used for further evaluation. Physicians consider these findings along with other clinical factors to decide on the final treatment and valve deployment. About 230 patients are expected to undergo TAVR using the Sapien 3 valve. Participants will have data collected at several points: before the procedure, during the procedure, at hospital discharge, and at 30 days and one year after the procedure for TAVR patients. SAVR patients will have data collected only at baseline and during their procedure. The main outcome measured is the proportion of cases achieving technical success immediately after the procedure. The study includes sites across Canada, Latin America, the Middle East, and Asia Pacific regions.

Endometrial cancer is the most common gynecological cancer, and this trial focuses on early-stage disease confined to the uterus. Researchers are evaluating the value of sentinel node biopsy (SNB) compared to no retroperitoneal lymph node dissection in treatment. The study aims to determine if SNB affects patient outcomes, costs, and potential harms such as lymphedema, while also assessing disease-free survival over time. This is a Phase III randomized clinical trial designed to clarify these important questions. Participants will be randomly assigned to one of two groups: one receiving hysterectomy and removal of fallopian tubes and ovaries with SNB, and the other receiving the same surgery without retroperitoneal node dissection. The SNB procedure involves injecting a tracer dye near the tumor to identify the first lymph node(s) that drain the area, which are then surgically removed. For some younger women with less invasive cancer, ovary removal may be omitted. Treatment details, including surgery and biopsy procedures, will be carefully followed. Throughout the study, participants will be monitored for recovery and side effects such as lymphoedema, quality of life, and adverse events. Researchers will use clinical exams, imaging, and pathology to check for disease recurrence up to 4.5 years after surgery. Other assessments include cost-effectiveness, patient-reported outcomes, and survival. The primary outcomes are the time to return to usual activities at 12 months and disease-free survival at 4.5 years. Safety and health will be closely tracked, with a total follow-up period extending beyond four years.

Researchers are evaluating the safety and effectiveness of the F2 Cerebral Protection System (CPS) compared to standard care in patients undergoing Transfemoral Transcatheter Aortic Valve Replacement (TF TAVR) for aortic stenosis and aortic diseases. This trial aims to show that the F2 CPS performs consistently with control devices in safety and is superior in effectiveness during TF TAVR procedures. Participants will receive Transcatheter Aortic Valve Replacement using commercially available devices. One group will have the F2 Filter and Delivery System used during the procedure, while the control group will receive standard care, which may include no protection or use of the Sentinel Cerebral Protection System. The study is prospective, randomized, multicenter, and single-blind. During the study, participants will be monitored for major adverse cardiac and cerebrovascular events within 30 days after the procedure and new brain lesion volume 8 to 72 hours post-procedure. Follow-up evaluations and safety assessments will be conducted according to the protocol. Participants must be willing and able to comply with follow-up visits and assessments throughout the study period.