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: March 6, 2013

Last verified: March 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	April 29, 2010
Last Updated Date	March 6, 2013
Start Date ^ICMJE	April 2010
Primary Completion Date	October 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: April 29, 2010)	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
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01113983 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: April 29, 2010)	Adverse Event Rate [ Time Frame: 5 Years ] [ Designated as safety issue: Yes ] Adverse Event Rate
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Transfemoral & Transapical Placement of Aortic Balloon Expandable Transcatheter Valves Trial (JAPAN)
Official Title ^ICMJE	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. 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
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Aortic Valve Stenosis Efficacy Endpoints Improvement of Aortic Valve Area and NYHA Functional Classification
Intervention ^ICMJE	Drug: Transcatheter aortic valve implantation Transcatheter aortic valve implantation via transfemoral or transapical approach Other Names: SAPIEN XT NovaFlex delivery system Ascendra2 delivery system
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	69
Estimated Completion Date	April 2016
Primary Completion Date	October 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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 %
Gender	Both
Ages	Not Provided
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Japan

Administrative Information
NCT Number ^ICMJE	NCT01113983
Other Study ID Numbers ^ICMJE	EW-P-001
Has Data Monitoring Committee	Yes
Responsible Party	Edwards Lifesciences
Study Sponsor ^ICMJE	Edwards Lifesciences
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Edwards Lifesciences
Verification Date	March 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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