TARGET 2.0 Study: Safety and Performance of the Cardiovalve Tricuspid Valve Replacement System in the Treatment of Subjects With Tricuspid Regurgitation- Investigation
This investigation is a continuation for TARGET investigation and its purpose is to further demonstrate the efficiency and safety of the Cardiovalve system in the treatment of subjects with tricuspid regurgitation. The same subject population will be included, while applying the clinical and scientific knowledge accumulated in the TARGET investigation. This investigation will support the submission for obtaining marketing approval.
• Subject is ≥ 18 and \<85 years
• Severe tricuspid regurgitation (TR) ≥3+ based upon echocardiography, as assessed by independent core laboratory using a 5-grade classification (mild (1), moderate (2), severe (3), massive (4), torrential (5)). Trace and no TR is considered 0)29
• Symptomatic, NYHA Class II-IV
• Left ventricular ejection fraction (LVEF) ≥ 30%
• Subject adequately treated based upon medical standards
• Subjects are at high risk for open heart surgery
• Subject provided written, informed consent before investigation enrollment
• Subject approved by the Subject Screening Committee
• Anatomical Inclusion Criteria (measured by CT)
• Right femoral vein diameter \> 9mm
⁃ Tricuspid valve diameter \< 55 mm
⁃ RV length \> 45 mm