CoreValve™ Evolut R™ FORWARD Study
CoreValve™ Evolut R™ FORWARD Study
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