Overview
Transfemoral & Transapical Placement of Aortic Balloon Expandable Transcatheter Valves Trial (JAPAN)
Status:
Unknown status
Unknown status
Trial end date:
0000-00-00
0000-00-00
Target enrollment:
69
69
Participant gender:
Both
Both
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.Phase:
N/AAccepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Edwards LifesciencesLast Updated:
2014-02-19
Criteria
Inclusion Criteria:- Primary:
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:
- Primary:
Aortic valve is congenital unicuspid or bicuspid Annulus size between < 18 mm or > 25 mm
LVEF < 20 %