for people ages 18 years and up (full criteria)
at Sacramento, California and other locations
study started
estimated completion
Jason Rogers, M.D.



Prospective, controlled, multicenter clinical investigation with two trial arms: surgical and non-surgical. Subjects in the surgical arm will be randomized in a 2:1 ratio to the trial device or to conventional mitral valve surgery. Subjects in the non-surgical arm will receive the trial device. Subjects will be seen at screening, pre- and post-procedure, discharge, 30 days, 3 months, 6 months, and annually through 5 years.

Official Title

Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation


Mitral Regurgitation Mitral Insufficiency Mitral Valve Insufficiency Cardiovascular Diseases Valve Disease, Heart Heart Valve Diseases Functional Mitral Regurgitation Degenerative Mitral Valve Disease Vomiting Heart Diseases Tendyne Mitral Valve System Surgical mitral valve repair or replacement


You can join if…

Open to people ages 18 years and up

  • Symptomatic, severe mitral regurgitation
  • NYHA Functional Classification ≥ II (if Class IV, patient must be ambulatory).
  • The local site heart team determines that the subject has been adequately treated per applicable standards
  • Not a member of a vulnerable population

You CAN'T join if...

  • Left ventricular ejection fraction < 25%
  • Left ventricular end diastolic diameter > 7.0 cm
  • Prior surgical or interventional treatment of mitral valve involving implantation of prosthetic material
  • Mitral pathoanatomy and left ventricular outflow tract anatomy deemed not suitable for Trial device implantation
  • Subjects with non-cardiac comorbidities that are likely to result in a life expectancy of less than 12 months.


  • University of California - Davis Medical Center accepting new patients
    Sacramento California 95817 United States
  • Los Robles Hospital and Medical Center accepting new patients
    Thousand Oaks California 91360 United States

Lead Scientist

  • Jason Rogers, M.D.
    Professor, Cardiovascular Medicine. Authored (or co-authored) 44 research publications


accepting new patients
Start Date
Completion Date
Tendyne Holdings, Inc.
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Study Type
Last Updated