N/A Completed N=218 Treatment

PREVAIL-TA: Placement of Aortic Balloon Expandable Transcatheter Valves Trial (Europe)

Aortic Valve Stenosis

Source: ClinicalTrials.gov NCT01238835 ↗

Enrolled (actual)

218

Serious AEs

92.2%

Results posted

Nov 2020

Primary outcomePrimary: Number of Deaths — 16 Participants

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Deaths	16	—
SECONDARY Number of Participants With a Stroke	4	—

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

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.