Mistral Percutaneous Tricuspid Valve Durable Repair Pivotal Study
The Mistral is an investigational device intended for percutaneous trans-catheter repair in high risk for surgery individuals suffering from functional Tricuspid Regurgitation (TR). The device system is to be used only in accordance with the approved Investigational Plan on subjects who have signed an informed consent form. Device use is limited to the approved study investigators.
• Patient is able and willing to give informed consent, follow protocol procedures, and comply with follow-up visit requirements
• Subject is ≥ 18 years of age or legal age in host country
• Minimum of moderate functional or degenerative tricuspid regurgitation:
‣ Subjects with moderate TR: Only NYHA (New York Heart Association) Class III or IV maybe considered for inclusion.
⁃ Subjects with severe or greater TR: NYHA (New York Heart Association) Class II, III, or IV may be considered for inclusion
• Subject has left ventricular ejection fraction (LVEF) \>20 %
• The subject is at high risk of mortality with tricuspid valve surgery as determined by the cardiac surgeon and an interventional cardiologist at the site (center heart team).
• Femoral or Jugular access of the Steerable Catheter with MDS (Mistral Delivery System) is determined to be feasible.
• Subject must agree not to start participating in any other clinical trial for a period of 6 months following the index procedure.
• As determined by the center heart team, the Mistral is the suitable treatment option.