Oakbrook Terrace

Researchers are comparing the rates of surgical and minimally invasive interventions, as well as any harms, in Medicare beneficiaries treated with the MILD procedure versus those treated with interspinous process decompression IPD for lumbar spinal stenosis with neurogenic claudication. This observational study uses Medicare claims data to follow patients for 24 months after their initial procedure starting from January 1, 2017. The purpose is to evaluate outcomes between these two types of procedures without requiring prior patient enrollment or consent. The study includes two groups patients who received MILD, which is a percutaneous image-guided lumbar decompression performed under fluoroscopic guidance through a dorsal approach to the spine, and patients who received IPD, a different device-based decompression procedure. Data on reoperations and complications will be collected for both groups over a 24-month follow-up period using Medicare claims. Enrollment continues until the sponsor decides to stop. Participants involvement is passive as the study uses existing Medicare claims data. Researchers will monitor rates of harms related to the initial procedure and subsequent surgical or minimally invasive interventions over two years. No direct patient visits or interventions are conducted, and the study is exempt from institutional review board oversight. The total study duration extends to December 2026, covering cases treated since early 2017.

Researchers are studying the accuracy of estimating VO2Max and other cardiopulmonary exercise test CPET measures using wearable biosensors that monitor daily activities. The study aims to develop and validate a machine learning algorithm that uses data from motion sensors and EKGs. A total of 1000 participants will enroll, including 100 healthy adults aged 18 to 80 and 900 participants undergoing CPET as part of standard care. Participants will be observed in two groups healthy individuals who undergo CPET and those receiving CPET during routine care. Data collected from these tests and wearable biosensors will feed into the algorithm development and validation process. There are no investigational treatments, as this is a non-interventional study focusing on data collection and algorithm evaluation. During the study, participants will undergo CPET assessments, and their biosensor data will be collected during daily activities. Researchers will monitor the performance of the machine learning algorithm by comparing its estimates to standard CPET results. The primary outcome is to gather data for algorithm development and validation by March 2025. Participants involvement includes consenting, following protocol procedures, and being available for the study duration.

This research aims to evaluate the safety and effectiveness of the HeartMate 3 left ventricular assist system LVAS compared to guideline-directed medical therapy GDMT in adults with advanced heart failure HF who are ambulatory and not dependent on intravenous inotropes. The study focuses on patients with elevated mean pulmonary artery pressure PAP due to left ventricular failure, a group at higher risk of worsening HF despite optimal medical treatment. The trial seeks to identify whether earlier intervention with LVAS benefits these patients. Participants will be divided into groups based on their mean PAP levels measured by the CardioMEMS PA Sensor device, which monitors pulmonary artery pressure remotely. Those with elevated mean PAP 30 mmHg are randomized either to receive the HeartMate 3 LVAS within 14 days or to continue with GDMT per heart failure guidelines. Patients with lower mean PAP <30 mmHg join a single-arm registry to observe their disease progression while on medical therapy. All participants either have or will receive the CardioMEMS PA Sensor implant as part of the study. During the trial, participants will undergo regular assessments including survival without major complications such as disabling stroke or worsening heart failure requiring urgent interventions over two years. Quality of life, exercise capacity via six-minute walk tests, hospitalization rates, and adverse events will also be closely monitored. The study involves approximately 850 subjects across about 75 sites worldwide and aims to provide data on how best to manage advanced HF patients using mechanical circulatory support versus medical therapy alone.