Prospective, single arm, multi-center, observational, post market study to document the clinical and device performance outcomes of the Evolut R system used in routine hospital practice in a large patient cohort for the treatment of symptomatic native aortic valve stenosis or a stenosed, insufficient, or combined surgical bioprosthetic valve failure necessitating valve replacement.

The study objective is to document the clinical and device performance outcomes of the Evolut R system used in routine hospital practice in a large patient cohort for the treatment of symptomatic native aortic valve stenosis or a stenosed, insufficient, or combined surgical bioprosthetic valve failure necessitating valve replacement.

Prospective, single arm, multi-center, observational, post market study. In Australia and Canada it is a prospective, single arm, multi-center pre-market study.

Up to 60 centers worldwide. Geographies may include Europe, Australia, Middle East and Africa, Latin America and Canada.

Approximately 1000 implanted subjects, consented for follow-up through three years.

For each subject, data will be collected preoperatively, intra-operatively, at hospital discharge, 30 days, 1, 2 and 3 years.

Inclusion Criteria:

• Symptomatic native aortic valve stenosis or a stenosed, insufficient, or combined surgical bioprosthetic valve failure necessitating valve replacement

• Acceptable candidate for elective treatment with the Evolut R System and in conformity with the local regulatory and medico economic context

• Age ≥80 years OR considered to be at high or greater risk for surgical aortic valve replacement (AVR) where high risk is defined as:

  • Society of Thoracic Surgeons (STS) predicted risk of mortality ≥8% OR
  • Documented heart team agreement of risk for AVR due to frailty or comorbidities.

• Geographically stable and willing to return to the implanting site for all follow-up visits

• Of legal age to provide informed consent (patient Informed Consent or Data Release Form) in the country where they enroll in the trial

• The patient has been informed of the nature of the study, is able and willing to provide consent without assistance from a legal representative and has consented to participate, and has authorized the collection and release of his/her medical information by signing a Patient Informed Consent or Data Release Form.

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 R system
• Estimated life expectancy of less than 1 year
• Participating in another trial that may influence the outcome of this trial
• Need for emergency surgery for any reason

The study population includes patients with symptomatic native aortic valve stenosis or a stenosed, insufficient, or combined surgical bioprosthetic valve failure necessitating valve replacement who are scheduled for an elective transcatheter aortic valve implantation. Patients who will undergo an emergency procedure should not be included in this study.