Aortic Valve Stenosis Clinical Trial
Official title:
A Clinical Trial of a 20mm Transcatheter Bioprosthetic Valve for Patients With Aortic Stenosis
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
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