Investigational SAPIEN M3 System for mitral valve repair
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.
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
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
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 www.clinicaltrials.gov website for more details.