SAPIEN 3 Ultra EU PMS
SAPIEN 3 Ultra EU PMS
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.
This is a prospective, observational, single-arm, multicentre, post-market study.
Inclusion Criteria:

 1. Will undergo TAVI with the Edwards SAPIEN 3 Ultra System

 2. Less than 80 years of age at time of the procedure

 3. Low surgical risk

 4. Meets clinical and procedural requirements for early discharge

 5. 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

 Exclusion Criteria:

 1. Medical, social, or psychological conditions that preclude appropriate consent and
 follow-up, including subjects under guardianship

 2. Considered to be part of a vulnerable population

 3. Active SARS-CoV-2 infection (Coronavirus-19 [COVID-19]) or previously diagnosed with
 COVID-19 with sequelae that could confound endpoint assessments

 4. Cannot tolerate an anticoagulation/antiplatelet regimen

 5. Active bacterial endocarditis

 6. Participating in a drug or device study that has not reached its primary endpoint