FORWARD PRO Study Interventional Post-market Study With the Evolut™ PRO System

FORWARD PRO Study Interventional Post-market Study With the Evolut™ PRO System

Prospective, single-arm, multi-center, interventional post-market study. After signing informed consent, eligible subjects will be implanted with the CE marked Evolut™ PRO system.

The investigation purpose is to evaluate the acute and long term clinical performance and safety of Evolut™ PRO in a routine hospital setting in patients with symptomatic native aortic valve stenosis or a stenosed, insufficient, or combined surgical bioprosthetic valve failure necessitating valve replacement within the approved intended use in local geography.

Approximately 600 subjects implanted with the Evolut™ PRO at up to 40 sites in Europe. Other regions may be added depending on the regulatory status of the device.

Inclusion Criteria:

• Symptomatic native aortic valve stenosis or a stenosed, insufficient, or combined surgical bioprosthetic valve failure necessitating valve replacement
• High or greater risk for surgical aortic valve replacement as estimated by the heart team OR, 75 years or older and at intermediate risk for surgical AVR (STS risk score ≥4% or with an estimated hospital mortality ≥4% as assessed by the heart team)
• Acceptable candidate for treatment with the Evolut™ PRO system in conformity with the Instructions for Use and the local regulations
• Able and willing to return to the implanting site at the following follow-up visits: 1-year, 3-year and 5-year
• Written informed consent obtained without assistance from a legal representative prior to enrollment in the study.

Exclusion Criteria:

• Known hypersensitivity or contraindication to aspirin, heparin (HIT/HITTS) and bivalirudin, ticlopidine, clopidogrel, Nitinol (Titanium or Nickel), or sensitivity to contrast media, which cannot be adequately premedicated
• Preexisting mechanical heart valve in aortic position
• Ongoing sepsis, including active endocarditis
• Anatomically not suitable for the Evolut™ PRO system
• Estimated life expectancy of less than 1 year
• Participating in another trial that may influence the outcome of this study
• Need for emergency surgery for any reason
• Inability to understand and respond to the quality of life questionnaire