Mitral valve disease resulting in mitral regurgitation (MR ≥ Grade III) and/or severe mitral valve stenosis (mitral valve area ≤ 1.5cm²) per American Society of Echocardiography criteria.
LVEF ≥ 30%.
In the judgement of the Site Heart Team, transcatheter therapy is deemed more appropriate than open heart surgery.
Prior surgical or interventional treatment that interferes with the Cephea valve delivery or function.
Need for emergent or urgent surgery.
Sites
Instituto do Coração do HCFMUSP
Recruiting
Av. Dr. Enéas Carvalho de Aguiar, 44 - 1° andar, sala 2 - Cerqueira César, São Paulo - SP, CEP: 05403-000
Instituto Nacional del Tórax - Santiago de Chile
Recruiting
José Manuel Infante 717, Providencia, Región Metropolitana, Chile
Hospital San Borja Arriarán
Recruiting
Av. Sta. Rosa 1234, 8360160 Santiago, Región Metropolitana, Chile
