CardiAQ-Edwards™ Transcatheter Mitral Valve Replacement (TMVR) Study
CardiAQ-Edwards™ Transcatheter Mitral Valve Replacement (TMVR) Study
Clinical study to evaluate the safety and performance of the CardiAQ-Edwards™ Transcatheter
 Mitral Valve
The study is a multi-center, prospective, single-arm, and non-randomized study designed to
 evaluate the safety and performance of the CardiAQ-Edwards™ Transcatheter Mitral Valve with
 transapical and transseptal delivery systems in patients with degenerative or
 functional/ischemic mitral regurgitation.
Inclusion Criteria:

 -  NYHA ≥ II

 -  Moderate/severe or severe mitral regurgitation

 -  Prohibitive risk for open-heart surgery

 -  Meets anatomical criteria

 Exclusion Criteria:

 -  Unsuitable anatomy

 -  Need for emergent or urgent surgery

 -  Prior mechanical aortic valve replacement

 -  Any prior surgical or transcatheter repair (excluding balloon valvuloplasty) or
 replacement of the mitral valve

 -  Preexisting device in the left ventricular apex

 -  Clinically significant, untreated coronary artery disease

 -  Limited life expectancy (< 12 months)

 -  Active infection