N/A
Completed N=500
SAPIEN 3 Ultra EU PMS
Source: ClinicalTrials.gov NCT04860752 ↗Enrolled (actual)
500
Serious AEs
31.4%
Results posted
Jul 2025
Primary outcomePrimary: Length of Index Hospitalization — 3.3 days
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Length of Index Hospitalization |
3.3 | — |
| SECONDARY Death |
9 | — |
| SECONDARY Stroke |
7 | — |
| SECONDARY New Requirement for Permanent Pacemaker |
51 | — |
| SECONDARY Aortic Valve Reintervention |
3 | — |
| SECONDARY Aortic Regurgitation |
2 | — |
| SECONDARY Mean Gradient |
12.8 | — |
| SECONDARY Effective Orifice Area |
1.6 | — |
| SECONDARY Discharge Location |
436 | — |
Eligibility Criteria
Inclusion Criteria
- 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
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
- Active SARS-CoV-2 infection (Coronavirus-19 [COVID-19]) or previously diagnosed with COVID-19 with sequelae that could confound endpoint assessments
- Cannot tolerate an anticoagulation/antiplatelet regimen
- Active bacterial endocarditis
- Participating in a drug or device study that has not reached its primary endpoint
Data sourced from ClinicalTrials.gov (NCT04860752). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.