Palm Beach

Researchers are evaluating surgical and minimally invasive treatments for lumbar spinal stenosis (LSS) by comparing Medicare patients who received the MILD procedure against those who had interspinous process decompression (IPD). The study focuses on outcomes such as the rate of harms related to the initial procedure and the frequency of additional surgical or minimally invasive interventions within 24 months after treatment. Enrollment includes patients treated from January 1, 2017, onward, with continuation until the sponsor decides to stop. The MILD procedure involves percutaneous image-guided lumbar decompression, performed under fluoroscopy through a dorsal approach to partially remove tissue and bone at the affected spinal level. The control group receives the IPD procedure for LSS. Both groups are monitored for a 24-month period post-index procedure using Medicare claims data to track reoperations and any harms. Participants contribute data through Medicare claims without needing prior enrollment or consent, as the study is exempt from IRB oversight. Researchers collect and analyze information on procedure-related harms and subsequent interventions over two years. This approach allows evaluation of long-term safety and effectiveness outcomes for patients treated with either MILD or IPD.

Researchers are evaluating the safety and effectiveness of the Carillon Mitral Contour System (CMCS) in treating patients with heart failure who have functional mitral regurgitation (FMR). This is a prospective, randomized, double-blinded, sham-controlled clinical trial involving 300 participants across sites in the United States, Canada, and Europe. The study aims to compare the CMCS implant procedure with a control group receiving a sham procedure to assess improvements in heart function and safety over time. Participants will be randomly assigned to one of two groups: an intervention group receiving the Carillon implant, which is placed in the coronary vein to reshape the mitral valve and reduce leakage, or a control group undergoing a similar procedure without implant placement. Both groups will continue receiving guideline-directed heart failure medications. Before randomization, participants undergo echocardiographic, coronary angiogram, and venogram evaluations to confirm eligibility and anatomical suitability for the implant. After the procedure, participants will have follow-up visits at 1, 6, 12, 18, and 24 months to monitor safety, heart function, and clinical status. After 24 months, the study will be unblinded, and participants will continue with annual contacts and echocardiograms for an additional 3 years, totaling 5 years of monitoring. Primary outcomes include freedom from major adverse events at 12 months and a clinical composite measure of efficacy at 24 months.