"TARGET 2.0 Study": Safety and Performance of the Cardiovalve TR Replacement System
Trial Parameters
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Subject is ≥ 18 and \<85 years 2. 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 3. Symptomatic, NYHA Class II-IV 4. Left ventricular ejection fraction (LVEF) ≥ 30% 5. Subject adequately treated based upon medical standards 6. Subjects are at high risk for open heart surgery 7. Subject provided written, informed consent before investigation enrollment 8. Subject approved by the Subject Screening Committee Anatomical Inclusion Criteria (measured by CT) 9. Right femoral vein diameter \> 9mm 10. Tricuspid valve diameter \< 55 mm 11. RV length \> 45 mm Exclusion Criteria: Subjects will be excluded from the investigation if fulfill any of the following criteria: 1. Cardiac anatomy deemed not suitable for the Cardiovalve TR system as evaluated (by CT) 2. Venous peripheral an