Early Feasibility Study of the HighLife 28mm Trans-Septal Mitral Valve Replacement System for Severe Mitral Regurgitation in High-Risk Patients

What this Trial Is About

Researchers are evaluating the HighLife 28mm Trans-Septal Transcatheter Mitral Valve Replacement TSMVR system in patients with moderate-severe or severe mitral regurgitation who are at high risk for surgery. This early feasibility study focuses on assessing the devices feasibility, safety, and performance, especially in patients with symptomatic mitral valve abnormalities who cannot undergo conventional surgery. The study is open-label, prospective, and conducted across multiple centers in the United States. The study uses the HighLife TSMVR system, which includes a 28 mm self-expanding mitral bioprosthesis with bovine pericardium leaflets and a sub-annular implant to stabilize the valve position. The device is delivered through a minimally invasive trans-septal approach. Patients receive this single-arm investigational treatment, designed as an alternative when medical therapy is maximized, and surgery is high-risk or unsuitable. The study evaluates the device mainly at 30 days post-procedure, with longer-term safety and performance also monitored. Participants will undergo assessments including imaging tests like CT and transesophageal echocardiography to confirm valve sizing and anatomy before treatment. After the procedure, researchers will monitor for major adverse events and the devices ongoing performance. The primary outcomes focus on safety and function at 30 days, while technical success is assessed immediately after implantation. The studys total duration extends through long-term follow-up to observe sustained outcomes and safety, with careful monitoring throughout the process.

An Early Feasibility Study of the HighLife 28mm Trans-Septal Transcatheter Mitral Valve Replacement System