N/A
N=17
PREVAIL-20J - Transfemoral Placement of 20mm Aortic Balloon Expandable Transcatheter Valve Trial
Aortic Valve Stenosis
Bottom Line
View on ClinicalTrials.gov: NCT01419015 ↗Enrolled (actual)
17
Serious AEs
47.1%
Results posted
Aug 2020
Primary outcome: Primary: NYHA Improvement and AVA >= 0.65 cm2 — 14 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- SAPIEN XT NovaFlex delivery system (Device)
- Age
- Adult, Older Adult · 19+ yrs
- Sex
- All
- Sponsor
- Edwards Lifesciences
- Primary completion
- Jan 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY NYHA Improvement and AVA >= 0.65 cm2 |
14 | — |
Summary
A single arm, prospective multicenter non-randomized pivotal clinical trial evaluating the 20mm Edwards SAPIEN XT™ transcatheter heart valve (model 9300TFX), NovaFlex™ transfemoral 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 19 mm
- LVEF < 20 %
Data sourced from ClinicalTrials.gov (NCT01419015). 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.