Research Study: HighLife
Condition:
mitral valve regurgitation
Study Sponsor: Highlife Medical, Inc.
Study Investigator: Paul Sorajja, MD
Study Contact: Jenny Nguyen
jennifer.nguyen@allina.com
612-863-9291
Every research study comes with its own unique risks and benefits; the study team will assess whether you’re an eligible candidate and ensure you’re provided with all the information you need to decide if participating is right for you.
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.
Eligibility Criteria:

  • Age ≥ 18 years.
  • Moderate-severe or severe mitral regurgitation (> 3+)
    • For Degenerative MR: EROA ≥ 40 mm2 or regurgitant volume ≥ 60ml
    • For Secondary MR: EROA > 30 mm2 or regurgitant volume > 45ml (i.e., MR ≥ moderate-severe or severe by ASE criteria)
  • Patient has New York Heart Association (NYHA) Functional Class II, III or ambulatory IV.
  • Patient is under guideline directed medical therapy, as reviewed and confirmed by the local multidisciplinary Heart Team, for at least one month.
  • Patient is high-risk for open-heart surgery based on the assessment of the multidisciplinary Heart Team using standard scoring systems and consideration of co-morbidities, frailty, and disability.
  • Patient meets the anatomical criteria for HighLife valve.
  • Patient is willing to participate in the study and provides signed informed consent.

Interested in participating in this study?

Reach out to the study contact directly, or fill out this form and we will contact you and assess whether you are an eligible candidate!