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Transfemoral Placement of 20mm Aortic Balloon Expandable Transcatheter Valve Trial (JAPAN) (PREVAIL20JAPAN)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Edwards Lifesciences
ClinicalTrials.gov Identifier:
NCT01419015
First received: August 16, 2011
Last updated: January 15, 2013
Last verified: January 2013
History of Changes

August 16, 2011
January 15, 2013
June 2011
March 2013   (final data collection date for primary outcome measure)
Improvement in indexed Aortic valve area (indexed AVA) and NYHA functional classification. [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
Improvement in indexed Aortic valve area (indexed AVA) and NYHA functional classification
Same as current
Complete list of historical versions of study NCT01419015 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 Placement of 20mm Aortic Balloon Expandable Transcatheter Valve Trial (JAPAN)
A Clinical Trial of a 20mm Transcatheter Bioprosthetic Valve for Patients With Aortic Stenosis

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.

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
Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Aortic Valve Stenosis
Device: Transcatheter aortic valve implantation (SAPIEN XT NovaFlex delivery system)
Transcatheter aortic valve implantation via transfemoral approach.
Other Names:
  • SAPIEN XT
  • NovaFlex 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
15
September 2017
March 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

Main:

  • 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:

Main:

  • Aortic valve is congenital unicuspid or bicuspid
  • Annulus size between < 16 mm or > 19 mm
  • LVEF < 20 %
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01419015
EW-P-002
Yes
Edwards Lifesciences
Edwards Lifesciences
Not Provided
Principal Investigator: Morimasa Takayama, MD Sakakibara Heart Institute
Edwards Lifesciences
January 2013

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