Oakbrook Terrace

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 whether VO2Max and other cardiopulmonary exercise test (CPET) parameters can be accurately estimated using biosignals collected from wearable sensors during daily activities. The study aims to develop and validate a machine learning algorithm to estimate VO2Max by analyzing motion data from accelerometers and cardiopulmonary variables from EKGs. A total of 1000 participants will be included, comprising 100 healthy individuals aged 18 to 80 and 900 patients undergoing standard CPET as part of their care. The study is observational and non-interventional, focusing on collecting data without altering the participants' treatments. Participants will wear biosensors to gather relevant physiological data during their routine activities alongside undergoing CPET as standard care. The data collected will be used to develop and test the performance of the VO2Max estimation algorithm. There are no specific treatment groups or interventions in this study. Participants will be monitored through biosensors and CPET assessments to gather the necessary data for the algorithm's development and validation. Researchers will evaluate the accuracy and reliability of the machine learning model in estimating VO2Max. The study is planned to complete data collection and evaluation by March 2025. Participant involvement includes signing informed consent, complying with study procedures, and undergoing CPET as part of their routine care.

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 who are ambulatory and not dependent on intravenous inotropes. The trial focuses on patients with New York Heart Association (NYHA) Class IIIB or IV heart failure who have had prior hospitalizations and elevated pulmonary artery pressure (PAP) due to left ventricular failure. It seeks to identify patients who may benefit from earlier intervention with mechanical circulatory support using objective PAP measurements. Participants will be involved in either a randomized arm or a single-arm registry. The randomized group will receive either the HeartMate 3 LVAS or continue with optimized GDMT, while the single-arm registry will include patients who do not meet the PAP threshold for randomization and will continue GDMT. PAP monitoring is conducted via the CardioMEMS PA Sensor, implanted before or during the trial. The HeartMate 3 LVAS is a mechanical pump that assists the left ventricle, and GDMT includes medications such as beta blockers, ACE inhibitors, ARBs, mineralocorticoid receptor antagonists, and SGLT2 inhibitors. Participants will undergo assessments including survival free of disabling stroke, need for device replacement, worsening heart failure requiring urgent transplantation or mechanical support, hospice enrollment, or dependence on intravenous inotropes over two years. The study includes regular monitoring of PAP via the CardioMEMS device and clinical evaluations to track heart failure progression and treatment outcomes. The trial will last at least two years to evaluate these long-term outcomes and device safety in this patient population.