NL-OMON46344RecruitingNot Applicable
FORWARD PRO Study - FORWARD PRO Study
Medtronic Trading NL BV0 sites180 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 180
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18 to 64 (—)
Inclusion Criteria
- •Patients must meet ALL of the following inclusion criteria:
- •1.Symptomatic native aortic valve stenosis or a stenosed,
- •insufficient, or combined surgical bioprosthetic valve failure necessitating valve replacement
- •2.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)
- •3.Acceptable candidate for treatment with the Evolut* PRO system in conformity with the local regulations
- •4.Able and willing to return to the implanting site at the following follow-up visits: 1-year, 3-year and 5-year
- •5.Written informed consent obtained without assistance from a legal representative prior to enrollment in the study
Exclusion Criteria
- •Patients are NOT eligible for study participation if they meet ANY of the following exclusion criteria:;1.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
- •2.Preexisting mechanical heart valve in aortic position
- •3.Ongoing sepsis, including active endocarditis
- •4.Anatomically not suitable for the Evolut* PRO system
- •5.Estimated life expectancy of less than 1 year
- •6.Participating in another trial that may influence the outcome of this study
- •7.Need for emergency surgery for any reason
- •8.Inability to understand and respond to the quality of life questionnaire
Investigators
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