Overview
The objective of this study is to evaluate the long term safety and effectiveness of the SAPIEN 3 Transcatheter Heart Valve system in real world setting.
Description
This is an observational, single-arm, multicentre, post-market study.
Eligibility
Inclusion Criteria:
- Patient with symptomatic, severe, calcified aortic stenosis who is appropriate for the treatment with transcatheter aortic valve replacement as determined by a heart team and will undergo TAVI with the Edwards SAPIEN 3 System as part of standard-of-care treatment
- All surgical risks as determined by the site Heart Team
- 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:
- Medical, social, or psychological conditions that preclude appropriate consent and follow-up, including subjects under guardianship
- Considered to be part of a vulnerable population
- Pre-existing mechanical or bioprosthetic aortic valve
- Active SARS-CoV-2 infection or previously diagnosed with COVID-19 with sequelae that could confound endpoint assessments
- Cannot tolerate an anticoagulation/antiplatelet regimen
- Evidence of intracardiac mass, thrombus, vegetation, active infection or endocarditis
- Tortuous or calcified vessels that would prevent safe entry of the dilators and sheath
- Participating in a drug or device study that has not reached its primary endpoint