Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2025-12-24 @ 10:56 PM
NCT ID:
NCT02592369
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT02592369
Study Brief:
Protocol Section:
NCT02592369