Evaluation of Clinical Outcomes of Transseptal Transcatheter Mitral Valve-in-Valve Replacement for Degenerated Bioprostheses - The China Mviv Registry
Mitral valve disease is the most common structure heart disease, and surgical valve replacement is an important treatment for severe mitral valve disease. There are 2 types of valve often been used, mechanical or biological protheses valves. Mechanical valve requires lifelong use of anticoagulants and take the risk of bleeding through all lifetime, but bioprotheses valve do not..
• Subject had a degenerated surgical mitral bioprosthesis with at least moderate to severe mitral regurgitation or severe stenosis with echocardiographically derived mitral valve area (MVA) of ≤1.5 cm2
• Subjiect is symptomatic from mitral valve disease, as demonstrated by reported NYHA Functional Class II or greater.
• Subject is at least 18 years old.
• Heart team (including cardiac surgeon) agree on eligibility including assessment that transeptal, transcatheter mitral valve replacement (TsMVR) and redo surgical mitral valve replacement (rSMVR) are appropriate.
• The study patient or the study patient's legal representative informed of the nature of the study, agreed to its provisions and provided written informed consent as approved by the Institutional Review Board (IRB) center.
• The study Subject agreed to comply with all required post-procedure follow-up visits including annual visits through 5 years and analysis close date visits, which was conducted as a phone/clinic follow-up.