N/A
N=218
PREVAIL-TA: Placement of Aortic Balloon Expandable Transcatheter Valves Trial (Europe)
Aortic Valve Stenosis
Bottom Line
View on ClinicalTrials.gov: NCT01238835 ↗Enrolled (actual)
218
Serious AEs
92.2%
Results posted
Nov 2020
Primary outcome: Primary: Number of Deaths — 16 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- SAPIEN XT™ Transapical aortic valve replacement (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Edwards Lifesciences
- Primary completion
- Feb 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Deaths |
16 | — |
| SECONDARY Number of Participants With a Stroke |
4 | — |
Summary
A single arm, prospective multicenter non-randomized confirmatory clinical trial evaluating the Edwards SAPIEN XT™ transcatheter heart valve (model 9300TFX; "study valve"), the next generation Ascendra™ transapical delivery system, and crimper accessories.
Eligibility Criteria
Inclusion:
- EuroSCORE of ≥ 15 %
- Severe senile degenerative aortic valve stenosis
- Symptomatic aortic valve stenosis
- Informed consent
- Compliance
Exclusion:
- Logistic Euroscore > 40 %
- Evidence of an acute myocardial infarction
- Congenital unicuspid or congenital bicuspid valve/ non-calcified
- Mixed aortic valve disease
Data sourced from ClinicalTrials.gov (NCT01238835). 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.