Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation
Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation
Prospective, controlled, multicenter clinical investigation with three trial cohorts:
 Randomized, Non-Randomized, and Mitral Annular Calcification (MAC). Subjects in the
 Randomized cohort will be randomized in a 1:1 ratio to the trial device or to the MitraClip
 system. Subjects in the Non-Randomized and MAC cohorts will receive the trial device.

 The objective of the Clinical Trial to Evaluate the Safety and Effectiveness of Using the
 Tendyne Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation (SUMMIT) is
 to evaluate the safety and effectiveness of the Tendyne Mitral Valve System for the treatment
 of patients with symptomatic, moderate-to-severe or severe mitral regurgitation or for
 patients with symptomatic mitral valve disease due to severe mitral annular calcification.

 This randomized controlled trial will provide the opportunity to evaluate the safety and
 clinical benefits of the Tendyne Mitral Valve System compared to the MitraClip System in
 patients with symptomatic, moderate-to-severe or severe mitral regurgitation, within approved
 MitraClip indications. In addition, the safety and effectiveness of the Tendyne Mitral Valve
 System will be evaluated in patients with severe mitral annular calcification who are at
 prohibitive risk for mitral valve surgery. Patients who are not suitable for mitral valve
 surgery for reasons other than severe mitral annular calcification and are also not suitable
 for transcatheter repair with MitraClip, will be enrolled in the Non-randomized cohort.

 Subjects will be seen at screening, pre- and post-procedure, discharge, 30 days, 3 months, 6
 months, and annually through 5 years.
Inclusion Criteria:

 -  Symptomatic, moderate-to-severe or severe mitral regurgitation, or severe mitral
 annular calcification (MAC)

 -  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

 Exclusion Criteria:

 -  Mitral valvular vegetation or mass

 -  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

 -  Aortic valve disease requiring surgery or transcatheter intervention

 -  Severe tricuspid regurgitation or any tricuspid valve disease requiring surgery or
 transcatheter intervention

 -  Any planned surgical / interventional procedure within 60 day prior to or following
 subject randomization

 -  Subject undergoing hemodialysis due to chronic renal failure

 -  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