SAPIEN 3 Ultra EU PMS

Completed

• Conditions: Aortic Stenosis; Aortic Valve Stenosis

• Registration Number: NCT04860752
• Lead Sponsor: Edwards Lifesciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-4-23
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

Inclusion Criteria:<br><br> 1. Will undergo TAVI with the Edwards SAPIEN 3 Ultra System<br><br> 2. Less than 80 years of age at time of the procedure<br><br> 3. Low surgical risk<br><br> 4. Meets clinical and procedural requirements for early discharge<br><br> 5. The subject or subject's legal representative has been informed of the nature of the<br> study, agrees to its provisions and has provided written informed consent<br><br>Exclusion Criteria:<br><br> 1. Medical, social, or psychological conditions that preclude appropriate consent and<br> follow-up, including subjects under guardianship<br><br> 2. Considered to be part of a vulnerable population<br><br> 3. Active SARS-CoV-2 infection (Coronavirus-19 [COVID-19]) or previously diagnosed with<br> COVID-19 with sequelae that could confound endpoint assessments<br><br> 4. Cannot tolerate an anticoagulation/antiplatelet regimen<br><br> 5. Active bacterial endocarditis<br><br> 6. Participating in a drug or device study that has not reached its primary endpoint

Exclusion Criteria

Not provided

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Length of index hospitalization