N/A N=64 Treatment

PREVAIL-J - Transfemoral & Transapical Placement of Aortic Balloon Expandable Transcatheter Valves Trial (Japan)

Aortic Valve Stenosis

Bottom Line

View on ClinicalTrials.gov: NCT01113983 ↗

Enrolled (actual)

Serious AEs

81.3%

Results posted

May 2020

Primary outcome: Primary: Improvement of the AVA and NYHA Functional Classification — 38.2; 45.8 % of participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Transcatheter aortic valve implantation (Device)
Age: Pediatric, Adult, Older Adult
Sex: All
Sponsor: Edwards Lifesciences
Primary completion: Oct 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Improvement of the AVA and NYHA Functional Classification	38.2; 45.8	—
SECONDARY Death	5.4; 18.5	—

Summary

A single arm, prospective multicenter non-randomized pivotal clinical trial evaluating the Edwards SAPIEN XT™ transcatheter heart valve (model 9300TFX), NovaFlex™ transfemoral delivery system, Ascendra2™ transapical delivery system and crimper accessories. The trial includes a premarket pivotal cohort to evaluate the system performance as well as a post market clinical follow-up phase involving long term follow-up of all patients to evaluate the safety of investigational devices up to 5 years.

Eligibility Criteria

Inclusion Criteria

Patients who were judged difficult to safely undergo AVR
Severe senile degenerative aortic valve stenosis
NYHA Functional Class II or greater
Signed Informed Consent

Exclusion Criteria

Aortic valve is congenital unicuspid or bicuspid
Annulus size between 25 mm
LVEF < 20 %

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01113983). 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.