Louisville

Researchers are conducting a prospective study to collect blood pressure waveforms using CardiacSense CS BP Watch and CS BP Pillow Systems alongside arterial line A-line data and auscultatory blood pressure cuff measurements. The collected data aims to support the development of algorithms for the CS BP Systems. The study involves adult volunteers aged 50 to 80 years and includes a screening phase followed by a blood pressure data collection session. Participants who meet eligibility criteria will wear two CS BP Watches one on each hand and a CS BP Pillow. An arterial line will be inserted into the radial artery to provide reference blood pressure data. The study includes simultaneous recordings from these devices and periodic dual-observer auscultatory BP cuff measurements over a one-hour period. After data collection, devices are removed, and any adverse events are recorded. Participants will provide demographic and medical history information during screening, along with physical measurements such as wrist and bicep circumference and baseline vital signs. Eligibility tests include a modified Allens test and signal quality assessments for the devices. The primary outcome is the number of participants completing the full protocol with multi-modal physiological signal acquisition in one hour. The study ends after at least 100 valid datasets are collected, including follow-up for any adverse events after device removal.

This research investigates a new maternal fetal monitoring device designed to assist healthcare professionals in tracking fetal and maternal health during twin pregnancies. The study aims to collect clinical data by continuously monitoring and distinguishing fetal heart rates FHRs from twins using ultrasound Doppler transducers from both the investigational device and a marketed ultrasound imaging device. This helps support clinical decisions regarding fetal health during pregnancy and delivery. Pregnant women with twin pregnancies at 30 weeks gestation or later will participate in a single 40-minute monitoring session. During this session, the investigational device uses two Doppler transducers to capture fetal heart rates for each twin after confirming fetal presentation and positions by ultrasound imaging. Maternal pulse rate is also monitored using a SpO2 sensor, and investigators will adjust the transducers as needed to maintain continuous data collection. Participants will undergo this monitoring session while researchers collect fetal heart rate data and maternal pulse rates. The primary outcomes measured are the collection of distinct fetal heart rates and maternal pulse rates over 40 minutes. Safety events will be tracked for four months after participation. This study is sponsored by GE Healthcare and does not include patient advisors.

Researchers are evaluating the Persona Revision Knee System in patients who have previously undergone primary or revision total knee arthroplasty TKA. This observational study aims to assess the devices performance, clinical benefits, and safety through a retrospective cohort with prospective follow-up. The study involves patients treated with this knee system at up to 20 sites, with a maximum enrollment of 380 participants. The study includes patients implanted with various configurations of the Persona Revision Knee System, including different tibial stems, tibial components, articular surfaces, and femoral components. Participants are identified retrospectively and then invited to participate in prospective data collection at 1, 2, 3, 4, 5, 7, and 10 years after surgery. The device and any compatible instruments used follow the approved instructions for use. Participants will provide data through scheduled follow-up visits over several years, with assessments including the Knee Society Clinical Rating System objective knee score at 2 years as the primary outcome. Secondary measures include adverse events, pain scores, and knee function scores. The study monitors safety and clinical outcomes over time, with a total participation duration potentially extending up to 10 years postoperatively.