Safety and Feasibility Study of ContraBand Device Implantation for Treatment of Left-Sided Heart Failure in Adults Aged 18 to 85

What this Trial Is About

Researchers are evaluating the ContraBand12 device, a transcatheter constriction implant placed in the left and right branch pulmonary arteries to treat left-sided heart failure. This early feasibility study aims to assess how the device reduces pulmonary artery pressure and improves heart function during exercise, potentially enhancing physical capacity and prognosis for heart failure patients. The study is prospective, multi-center, interventional, open-label, and single-arm, focusing on safety and device feasibility. The intervention involves percutaneous implantation of the ContraBand devices through right heart catheterization. The device works by locally narrowing the pulmonary arteries, which lowers distal systolic pulmonary artery pressure and reduces the rise in pulmonary capillary wedge pressure during exercise. This change reflects improved left ventricular filling and cardiac output. There is no comparator group all participants receive the ContraBand implant. Participants will be monitored for device- or procedure-related major adverse events within 30 days and procedural success during implantation. Assessments include six-minute walk test distance and heart function measures. The study enrolls adults aged 18 to 85 with symptomatic left heart failure, and participants will be followed for safety and functional outcomes. The total study duration extends up to the end date in 2032, with detailed follow-up to evaluate feasibility and safety.

ContraBand™: Safety & Feasibility Study (RM-20-01)