China S3 PMS: SAPIEN 3 China Post Market Registry Study

This is an observational, single-arm, multicentre, post-market study.

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