Transfemoral & Transapical Placement of Aortic Balloon Expandable Transcatheter Valves Trial (JAPAN) (PREVAIL JAPAN)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Edwards Lifesciences
ClinicalTrials.gov Identifier:
NCT01113983
First received: April 29, 2010
Last updated: February 19, 2014
Last verified: February 2014

April 29, 2010
February 19, 2014
April 2010
October 2011   (final data collection date for primary outcome measure)
improvement in Aortic valve area (AVA) and NYHA functional classification [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]
improvement in Aortic valve area (AVA) and NYHA functional classification
Same as current
Complete list of historical versions of study NCT01113983 on ClinicalTrials.gov Archive Site
Adverse Event Rate [ Time Frame: 5 Years ] [ Designated as safety issue: Yes ]
Adverse Event Rate
Same as current
Not Provided
Not Provided
 
Transfemoral & Transapical Placement of Aortic Balloon Expandable Transcatheter Valves Trial (JAPAN)
A Clinical Trial of a Transcatheter Bioprosthetic Valve for Patients With Aortic Stenosis

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.

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.

Enrollment: 69 patients Transfemoral approach: 42 patients (No. of patients needed: 23) Transapical approach: 27 patients (No. of patients needed: 19)

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: Osaka University Hospital Kurashiki Central Hospital Sakakibara Heart Institute

Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Aortic Valve Stenosis
  • Efficacy Endpoints Improvement of Aortic Valve Area and NYHA Functional Classification
Drug: Transcatheter aortic valve implantation
Transcatheter aortic valve implantation via transfemoral or transapical approach
Other Names:
  • SAPIEN XT
  • NovaFlex delivery system
  • Ascendra2 delivery system
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
69
April 2016
October 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Primary:

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:

  • Primary:

Aortic valve is congenital unicuspid or bicuspid Annulus size between < 18 mm or > 25 mm LVEF < 20 %

Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01113983
EW-P-001
Yes
Edwards Lifesciences
Edwards Lifesciences
Not Provided
Not Provided
Edwards Lifesciences
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP