RecruitingMitral Regurgitation

An Early Feasibility Study of the HighLife 28mm Trans-Septal Transcatheter Mitral Valve Replacement System

Eligible age

18+ yrs

Accepts

All genders

Locations

10 states

Healthy volunteers

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About this study

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.

Sponsor: HighLife SAS

You may qualify if…

✓ 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
✓ Main Exclusion Criteria: