Palos Park

Researchers are evaluating the safety and effectiveness of the Cordella™ Pulmonary Artery Sensor System in patients with heart failure classified as New York Heart Association (NYHA) Class II and III. This prospective, multi-center, open-label, randomized clinical trial includes patients who have been diagnosed and treated for heart failure for at least three months and are receiving appropriate medical therapy. The study aims to monitor pulmonary artery pressure (PAP) data to help manage heart failure and reduce hospitalizations. The trial includes five study arms: three for NYHA II patients—Treatment Arm, Active Control Arm, and Crossover Arm—and two for NYHA III patients, including a randomized sub-study to assess a clinician-directed patient self-management strategy. The Cordella PA Sensor System consists of seven components working together to measure and transmit daily PAP readings from the patient's home to healthcare providers. Patients use the myCordella™ Patient Reader to record data, which is then analyzed for clinical assessment and management. Participants will be involved in daily PAP measurements at home, holding the patient reader device against their chest for about two minutes while seated. They must have sufficient eyesight, hearing, mental capacity, and internet coverage to operate the system. Researchers will monitor safety outcomes such as device complications and sensor failures, as well as efficacy outcomes like heart failure events or cardiovascular death over up to 24 months. Regular follow-up visits are required to assess device performance, patient condition, and study outcomes.

Researchers are evaluating the TricValve4 Transcatheter Bicaval Valve System in people with severe tricuspid regurgitation who are considered high risk for tricuspid valve surgery. This prospective multicenter clinical trial aims to assess the safety and effectiveness of this device in improving patient outcomes. The device is designed to be implanted without disturbing the native tricuspid valve and is made of bovine pericardium leaflets on a self-expanding nitinol stent system. The TricValve System includes two valves for the superior and inferior vena cava, which are pre-mounted in a delivery system for percutaneous implantation through the transfemoral approach. This single-use, sterile device comes in different sizes to fit the vena cava and is implanted without requiring open-heart surgery. After implantation, patients will be followed closely for 12 months, with annual follow-ups for up to 5 years to collect long-term safety and effectiveness data. Participants will undergo various assessments including measurements of mortality, stroke, pulmonary embolism, bleeding complications, vascular and cardiac complications, kidney injury, heart failure events, and valve-related surgeries over 1 month and 12 months. Functional and quality-of-life outcomes such as the Kansas City Cardiomyopathy Questionnaire score, New York Heart Association class, and a six-minute walking test will also be evaluated. The total participation period includes close follow-up immediately after the procedure and extended monitoring annually for up to 5 years.