Investigational SAPIEN M3 System for mitral valve repair

Trial ID:
Curtiss Stinis, MD
To establish the safety and effectiveness of the SAPIEN M3 System in subjects with symptomatic, at least 3+ mitral regurgitation for whom commercially available surgical or transcatheter treatment options are deemed unsuitable due to clinical, anatomic or technical considerations.

Inclusion Criteria

Patients must:
  • Be 18 years of age or older
  • Have moderate-severe to severe mitral regurgitation
  • Be considered unsuitable for commercially available surgical or transcatheter treatment options as determined by the Heart Team
  • Meet all other eligibility criteria

Exclusion Criteria

Patients must not:
  • Have another implanted device that will contact or interfere with the SAPIEN M3 System
  • Have Left Ventricular Ejection Fraction < 25%
  • Need aortic, tricuspid or pulmonic valve intervention within the next 12 months
  • Have history of heart transplant
  • Have active bacterial endocarditis within 180 days of the procedure

Additional Info

  • The Edwards SAPIEN M3 valve System is intended for replacement of the mitral valve via transceptal access in patients who are ineligible for mitral valve surgery and have complex anatomy.
  • An independent Case Review Board will review submitted cases to determine eligibility. All patients who qualify will receive the SAPIEN M3 device. Post-procedure follow-up visits will occur at 30 days, 6 months, 12 months and then annually for up to 5 years.
  • Search for NCT #04153292 at website for more details.

Contact Info:

  • Clinical Research Services