FORWARD PRO Study Interventional Post-market Study With the Evolut™ PRO System
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A vizsgálat adatai
- Ki végzi
- Medtronic Cardiovascular
- Azonosító
- NCT03417011
- A regiszteradat frissítve
- 2025. szeptember 9.
- Eredeti leírás
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.A teljes eredeti leírásKevesebb
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.
Bevonási feltételek: 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.
Kizáró feltételek: Need for emergency surgery for any reason; 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; Inability to understand and respond to the quality of life questionnaire.