First in Man Study of the JenaValve TAVI Plus System Transfemoral

First in Man Study of the JenaValve TAVI Plus System Transfemoral

The objective of this study is to evaluate feasibility, safety and effectiveness of the first generation transfemoral JenaValve Pericardial TAVR System (formerly named JenaValve TAVI Plus System- Transfemoral) in an elderly patient population with severe aortic stenosis who are at high risk for surgical aortic valve replacement.

The study is designed as a prospective, multi-center trial conducted at 2 centers in Germany enrolling up to 12 subjects. Each patient will be followed for 2 years. The last patient's follow-up will end in February 2016. It is planned that the study will end in June 2016. Study endpoints are defined in accordance with the "Standardized endpoint definitions for transcatheter aortic valve implantation clinical trials: a consensus report from the Valve Academic Research Consortium (VARC-2)". These endpoint definitions combine the expertise of surgeons, interventionalists, medical cardiologists, clinical trial and other specialists and allow for comparison of different trials concerning effectiveness and safety in TAVI.

Inclusion Criteria:

• Diagnosed with severe native aortic valve stenosis
• NYHA functional class II or higher
• Increased risk for surgical aortic valve replacement
• Comply with post-operative follow-up visits and requirements

Exclusion Criteria:

• Combined aortic valve disease with severe aortic insufficiency
• Presence of moderate mitral insufficiency or previous mitral prosthesis
• Severe pulmonary hypertension
• Congenital uni- or bicuspid aortic valve
• Endocarditis or active infection
• Life expectancy < 12 months
• Need for emergency surgery for any reason