Palos Park

Researchers are evaluating the safety and effectiveness of the Cordella Pulmonary Artery Sensor System in adults with New York Heart Association NYHA Class II and III heart failure. This multi-center, open-label, randomized controlled trial aims to assess how well this device helps manage heart failure by providing daily pulmonary artery pressure PAP measurements to clinicians and patients. The study includes multiple groups to compare different management strategies and patient self-management approaches. Participants will receive the Cordella Sensor device, which measures and transmits daily PAP data along with other vital signs such as blood pressure, weight, heart rate, and oxygen saturation. Clinicians will manage patients heart failure therapy based on these data using guideline-directed medical therapy. Some participants will follow a clinician-directed patient self-management plan involving daily PAP measurement and medication adjustments. The trial includes several study arms for both NYHA Class II and III cohorts, with some participants potentially crossing over between groups after a period. During the study, participants will take daily measurements using the Cordella system and attend scheduled follow-up visits. Researchers will monitor heart failure events, hospitalizations, mortality, device safety, and pressure sensor performance over months to years. The primary outcomes include heart failure events or cardiovascular death at 6 to 24 months, and safety outcomes related to device complications and sensor failure. Secondary outcomes cover hospitalization rates, medication changes, quality of life, functional status, and economic analyses. Participants are expected to comply with device use and follow-up visits throughout the trial duration, which may extend up to five years.

Researchers are evaluating the TricValve Transcatheter Bicaval Valve System in people with severe tricuspid regurgitation who are considered high risk for surgery. This prospective multicenter study aims to assess the safety and effectiveness of this system in improving outcomes for symptomatic adults. The study is sponsored by PF Products Features USA Inc. and participants will be followed closely after treatment to gather long-term data for up to five years. The TricValve System includes two valves designed for placement in the superior and inferior vena cava without affecting the native tricuspid valve. These valves are made from bovine pericardium leaflets on a nitinol stent and are delivered percutaneously through the transfemoral approach. Participants will receive the TricValve implantation and continue to be managed with optimal medical therapy as directed by their physician. After the procedure, patients will be monitored closely for one year with ongoing annual assessments. During the study, patients will undergo evaluations to monitor mortality, stroke, pulmonary embolism, bleeding complications, kidney injury, and device-related events within specified timeframes. Researchers will also assess heart function, quality of life using the Kansas City Cardiomyopathy Questionnaire, and physical capacity through the Six Minute Walking Test over 12 months. Safety and efficacy data will be collected regularly, including technical success of device placement and heart failure events. Participants will be followed yearly for up to five years to observe long-term outcomes.