Study of the HighLife 28mm Transcatheter Mitral Valve for Treating Moderate-Severe or Severe Mitral Regurgitation in High Surgical Risk Patients

What this Trial Is About

Researchers are evaluating the safety and performance of the HighLife 28mm transcatheter, trans-septal Mitral Valve in patients who have moderate to severe mitral regurgitation and are considered high risk for traditional open-heart surgery. This study focuses on patients with significant mitral valve leakage and who have specific heart failure symptoms classified as New York Heart Association NYHA Class II, III, or ambulatory IV. The study is sponsored by HighLife SAS and aims to gather information on this device in a real-world setting without randomization. Participants will receive the HighLife Transcatheter Mitral Valve Replacement device through a trans-septal catheter procedure. This is a single-arm, non-randomized study where all participants undergo this intervention. The study will monitor the devices safety primarily within the first 30 days after implantation. The procedure is designed for patients who meet specific anatomical criteria and have been on guideline-directed medical therapy for at least one month. Throughout the study, participants will be closely followed with scheduled assessments to evaluate the devices safety and overall performance. Researchers will monitor for adverse events and clinical outcomes, focusing on the 30-day safety period after treatment. The study includes follow-up visits and evaluations to ensure participant well-being and to gather comprehensive data on the devices effects. Participation lasts according to the study protocol, with ongoing monitoring as needed.

Expanded Study of the HighLife 28mm Trans-septal Trans-catheter Mitral Valve in Patients With Moderate-severe or Severe Mitral Regurgitation and at High Surgical Risk