SAPIEN 3 Ultra EU PMS
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A vizsgálat adatai
- Ki végzi
- Edwards Lifesciences
- Azonosító
- NCT04860752
- A regiszteradat frissítve
- 2025. július 29.
- Eredeti leírás
This study will evaluate real-world outcomes for the SAPIEN 3 Ultra Transcatheter Heart Valve System in transcatheter aortic valve implantation centres that are implementing minimalist periprocedural practices and facilitating early discharge home.A teljes eredeti leírásKevesebb
SAPIEN 3 Ultra EU Post-Market Observational Study
This study will evaluate real-world outcomes for the SAPIEN 3 Ultra Transcatheter Heart Valve System in transcatheter aortic valve implantation centres that are implementing minimalist periprocedural practices and facilitating early discharge home.
Bevonási feltételek: Will undergo TAVI with the Edwards SAPIEN 3 Ultra System; Less than 80 years of age at time of the procedure; Low surgical risk; Meets clinical and procedural requirements for early discharge; The subject or subject's legal representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
Kizáró feltételek: Active SARS-CoV-2 infection (Coronavirus-19 [COVID-19]) or previously diagnosed with COVID-19 with sequelae that could confound endpoint assessments; Participating in a drug or device study that has not reached its primary endpoint; Medical, social, or psychological conditions that preclude appropriate consent and follow-up, including subjects under guardianship; Considered to be part of a vulnerable population; Cannot tolerate an anticoagulation/antiplatelet regimen; Active bacterial endocarditis.