CardiAQ-Edwards™ Transcatheter Mitral Valve Replacement (TMVR) Study

The RELIEF Trial: REduction or eLimination of mItral rEgurgitation in Degenerative or Functional Mitral Regurgitation With the CardiAQ-Edwards™ Transcatheter Mitral Valve

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