Spring Hill

Researchers are evaluating the effects of the ABC Bicuspid Sizing Algorithm on patients with bicuspid aortic stenosis undergoing transcatheter aortic valve replacement TAVR using the Sapien 3 valve. This international, multi-center study aims to determine if the algorithm improves technical success immediately after the procedure and device success 30 days later. The study also examines how additional imaging techniques like gated computed tomography and artificial intelligence-based simulations influence treatment decisions. The study involves about 290 patients eligible for TAVR or surgical aortic valve replacement SAVR. Physicians use the ABC Bicuspid Sizing Algorithm to guide treatment allocation between TAVR and SAVR, as well as valve sizing and deployment for those receiving TAVR. Some patients may have further evaluation with gated CT or AI simulations to assess risks. Data for TAVR patients is collected at baseline, during the procedure, at hospital discharge, 30 days after, and annually up to 5 years. SAVR patients have data collected at baseline and during the procedure only. Participants will undergo diagnostic imaging including CT scans evaluated with the sizing algorithm and may receive additional assessments if indicated. Researchers collect data on procedure success, device outcomes, conduction disturbances, pacemaker implants, stroke, vascular complications, mortality, valve function, and hospitalizations for heart failure over 5 years. Follow-up visits occur at 30 days and annually, allowing long-term monitoring of outcomes after treatment.

Researchers are evaluating the safety and effectiveness of the Edwards SAPIEN X4 and X4S Transcatheter Heart Valves THV in people with symptomatic, severe, calcific aortic stenosis. This is a prospective, single group, multicenter study that also includes a separate registry for participants with bicuspid aortic valve morphology. Participants will undergo transcatheter aortic valve replacement TAVR using the SAPIEN X4 or X4S valves. Those with bicuspid aortic valves will be enrolled in a distinct registry but will also undergo TAVR. The study focuses on implantation of these balloon-expandable heart valves as the main intervention. During the study, participants will be monitored for safety and outcomes like death and stroke over one year. Researchers will assess heart function through the Kansas City Cardiomyopathy Questionnaire and check for complications such as paravalvular leak and the need for a permanent pacemaker within 30 days. The total participation time includes follow-up assessments up to one year after valve implantation.

Researchers are evaluating the role of sentinel node biopsy SNB compared to no retroperitoneal node dissection in women with early-stage endometrial cancer. This study aims to assess whether SNB causes any harm such as lymphoedema or morbidity, its cost-effectiveness, and if it affects disease-free survival. The trial is conducted in two stages Stage 1 with 444 patients focuses on recovery and quality of life, while Stage 2 with an additional 316 patients examines long-term disease outcomes. Participants will undergo either total laparoscopic or robotic hysterectomy with bilateral salpingo-oophorectomy TH BSO combined with SNB using injected tracer dyes, or TH BSO without retroperitoneal node dissection. Some patients under 45 years with specific tumor features may keep their ovaries. Surgery may include omentectomy in high-risk cases. The SNB procedure involves identifying the first lymph node that drains the tumor area using dye injections. During the study, participants will be monitored for recovery including adverse events, lymphoedema, quality of life, and healthcare costs over 12 months. Long-term follow-up will measure disease-free survival and overall survival up to 4.5 years after surgery. Evaluations will include clinical assessments, imaging, patient questionnaires, and molecular testing. The research team will also track surgery details, hospital stays, and the need for additional treatments throughout the study period.

Researchers are evaluating the safety and effectiveness of the F2 Cerebral Protection System CPS compared to standard care in patients undergoing Transcatheter Aortic Valve Replacement TF TAVR. The study aims to show that the F2 CPS is as safe as the control group and superior in effectiveness for protecting the brain during this heart valve procedure. This trial is a prospective, randomized, single-blind study conducted across multiple centers to assess these devices in patients with aortic stenosis and related aortic diseases. Participants will receive either the F2 Cerebral Embolic Protection System or standard care, which may include the Sentinel Cerebral Protection System or no embolic protection device during their TF TAVR procedure. The study compares the new F2 filter device against the current standard of care to see how well it prevents embolic events during the valve replacement. The intervention involves using these devices during the heart procedure to capture debris that might cause stroke. During the study, participants will be monitored closely with assessments including brain imaging to measure new lesion volume within 8 to 72 hours after the procedure and follow-up evaluations up to 30 days post-procedure to track major adverse cardiac and cerebrovascular events, including stroke. Researchers will also evaluate safety and effectiveness through clinical exams and data collection about any complications. Participation involves multiple visits and evaluations to ensure participant safety and collect outcome data over the study period, which continues through January 2027.