PREVAIL-20J - Transfemoral Placement of 20mm Aortic Balloon Expandable Transcatheter Valve Trial (PREVAIL-20J)
|Study Design:||Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
|Official Title:||A Clinical Trial of a 20mm Transcatheter Bioprosthetic Valve for Patients With Aortic Stenosis|
- Improvement in indexed Aortic valve area (indexed AVA) and NYHA functional classification. [ Time Frame: 6 Months ]Improvement in indexed Aortic valve area (indexed AVA) and NYHA functional classification
- Adverse Event Rate [ Time Frame: 5 Years ]Adverse Event Rate
|Actual Study Start Date:||June 2011|
|Estimated Study Completion Date:||September 2017|
|Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
Experimental: TAVI-TF Approach
Transcatheter aortic valve implantation and transfemoral approach. SAPIEN XT NovaFlex delivery system will be used.
Device: SAPIEN XT NovaFlex delivery system
Transcatheter aortic valve implantation via transfemoral approach.
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.
1)Osaka University Hospital, 2)Kurashiki Central Hospital, 3)Sakakibara Heart Institute, 4) Kokura Memorial Hospital
Please refer to this study by its ClinicalTrials.gov identifier: NCT01419015
|Kokura Memorial Hospital|
|Kitakyushu, Fukuoka, Japan, 802-8555|
|Kurashiki Central Hospital|
|Kurashiki, Okayama, Japan, 710-8602|
|Osaka University Hospital|
|Suita, Osaka, Japan, 565-0871|
|Sakakibara Heart Institute|
|Fuchu, Toyko, Japan, 183-003|
|Principal Investigator:||Morimasa Takayama, MD||Sakakibara Heart Institute|