Brief Title
PREVAIL-J - Transfemoral & Transapical Placement of Aortic Balloon Expandable Transcatheter Valves Trial (Japan)
Official Title
A Clinical Trial of a Transcatheter Bioprosthetic Valve for Patients With Aortic Stenosis
Brief 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.
Detailed Description
Purpose: To evaluate the safety and efficacy of THV-9300 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. 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.
Study Type
Interventional
Primary Outcome
Improvement of the AVA and NYHA Functional Classification
Secondary Outcome
Death
Condition
Aortic Valve Stenosis
Intervention
Transcatheter aortic valve implantation
Study Arms / Comparison Groups
TAVI - TF and TA approach
Description: Transcatheter aortic valve implantation and transfemoral/ transapical approach
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
64
Start Date
April 1, 2010
Completion Date
May 2016
Primary Completion Date
October 2011
Eligibility Criteria
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 < 18 mm or > 25 mm - LVEF < 20 %
Gender
All
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Yoshiki Sawa, MD, PhD, ,
Location Countries
Japan
Location Countries
Japan
Administrative Informations
NCT ID
NCT01113983
Organization ID
EW-P-001
Responsible Party
Sponsor
Study Sponsor
Edwards Lifesciences
Study Sponsor
Yoshiki Sawa, MD, PhD, Principal Investigator, Osaka University Hospital
Verification Date
April 2020