Brief Title
PREVAIL-20J - Transfemoral Placement of 20mm Aortic Balloon Expandable Transcatheter Valve Trial
Official Title
A Clinical Trial of a 20mm Transcatheter Bioprosthetic Valve for Patients With Aortic Stenosis
Brief Summary
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.
Detailed Description
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
Study Type
Interventional
Primary Outcome
NYHA Improvement and AVA >= 0.65 cm2
Condition
Aortic Valve Stenosis
Intervention
SAPIEN XT NovaFlex delivery system
Study Arms / Comparison Groups
TAVI-TF Approach
Description: Transcatheter aortic valve implantation and transfemoral approach. SAPIEN XT NovaFlex delivery system will be used.
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
17
Start Date
June 2011
Completion Date
December 2017
Primary Completion Date
January 2013
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 < 16 mm or > 19 mm - LVEF < 20 %
Gender
All
Ages
19 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Morimasa Takayama, MD, ,
Location Countries
Japan
Location Countries
Japan
Administrative Informations
NCT ID
NCT01419015
Organization ID
EW-P-002
Responsible Party
Sponsor
Study Sponsor
Edwards Lifesciences
Study Sponsor
Morimasa Takayama, MD, Principal Investigator, Sakakibara Heart Institute
Verification Date
July 2020