An Early Feasibility Study of the HighLife 28mm Trans-Septal Transcatheter Mitral Valve Replacement System
Study to evaluate the feasibility, safety and performance of the HighLife trans-septal Transcatheter Mitral Valve in patients with moderate-severe and severe mitral regurgitation who are at high risk for surgical treatment.
• Age ≥ 18 years
• Severe mitral regurgitation
• New York Heart Association (NYHA) Functional Class II, III or ambulatory IV.
• Patient is under maximally tolerated GDMT (incl. CRT) for at least 3 months
• Multidisciplinary Heart Team consensus that the patient is inoperable or at high-risk for surgical repair/replacement due to significant co-morbid conditions
• Multidisciplinary Heart Team consensus that the patient is not a suitable candidate for other approved percutaneous repair therapy due to anatomical or medical conditions
• Patient meets the anatomical criteria for HighLife valve sizing as determined by CT and TEE