PREVAIL-20J - Transfemoral Placement of 20mm Aortic Balloon Expandable Transcatheter Valve Trial (PREVAIL-20J)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01419015|
Recruitment Status : Completed
First Posted : August 17, 2011
Last Update Posted : June 19, 2018
|Condition or disease||Intervention/treatment||Phase|
|Aortic Valve Stenosis||Device: SAPIEN XT NovaFlex delivery system||Not Applicable|
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||28 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Clinical Trial of a 20mm Transcatheter Bioprosthetic Valve for Patients With Aortic Stenosis|
|Actual Study Start Date :||June 2011|
|Actual Primary Completion Date :||January 2013|
|Actual Study Completion Date :||December 2017|
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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|