Summary

for people ages 18 years and up (full criteria)
at UC Davis
study started
estimated completion
Jason Rogers, M.D. (ucdavis)

Description

Summary

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

Keywords

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

Eligibility

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.

Locations

  • University of California - Davis Medical Center accepting new patients
    Sacramento California 95817 United States
  • Cedars-Sinai Medical Center accepting new patients
    Los Angeles California 90048 United States

Lead Scientist

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

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Tendyne Holdings, Inc.
ID
NCT03433274
Study Type
Interventional
Last Updated