PREVAIL-20J - Transfemoral Placement of 20mm Aortic Balloon Expandable Transcatheter Valve Trial
PREVAIL-20J - Transfemoral Placement of 20mm Aortic Balloon Expandable Transcatheter Valve Trial
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.
Purpose: To evaluate the safety and efficacy of THV-9300 (20mm) for patients who have severe
 symptomatic aortic stenosis attributed to calcification and degeneration of a valve leaflet
 and for whom undergoing a surgery safely would be difficult.

 Enrollment: 15 patients (No.of patients needed: 12)

 Follow-up: Subject data collection will include clinical information at baseline and during
 the index procedure. Subjects will undergo clinical follow-up at discharge, 30 days, 6 months
 and annually for 5 years.

 Clinical sites:

 1)Osaka University Hospital, 2)Kurashiki Central Hospital, 3)Sakakibara Heart Institute, 4)
 Kokura Memorial Hospital
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 < 16 mm or > 19 mm

 -  LVEF < 20 %