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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Edwards Lifesciences Identifier:
First received: August 16, 2011
Last updated: February 19, 2014
Last verified: February 2014

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.

Condition Intervention
Aortic Valve Stenosis
Device: Transcatheter aortic valve implantation (SAPIEN XT NovaFlex delivery system)

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Clinical Trial of a 20mm Transcatheter Bioprosthetic Valve for Patients With Aortic Stenosis

Resource links provided by NLM:

Further study details as provided by Edwards Lifesciences:

Primary Outcome Measures:
  • 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

Secondary Outcome Measures:
  • Adverse Event Rate [ Time Frame: 5 Years ] [ Designated as safety issue: Yes ]
    Adverse Event Rate

Estimated Enrollment: 15
Study Start Date: June 2011
Estimated Study Completion Date: September 2017
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Transcatheter aortic valve implantation (SAPIEN XT NovaFlex delivery system)
    Transcatheter aortic valve implantation via transfemoral approach.
    Other Names:
    • NovaFlex delivery system
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


Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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 %
  Contacts and Locations
Please refer to this study by its identifier: NCT01419015

Kokura Memorial Hospital
Kitakyushu, Fukuoka, Japan, 802-8555
Kurashiki Central Hospital
Kurashiki, Okayama, Japan, 710-8602
Osaka University Hospital
Suita, Osaka, Japan, 565-0871
Sakakibara Heart Institute
Fuchu, Toyko, Japan, 183-003
Sponsors and Collaborators
Edwards Lifesciences
Principal Investigator: Morimasa Takayama, MD Sakakibara Heart Institute
  More Information

No publications provided

Responsible Party: Edwards Lifesciences Identifier: NCT01419015     History of Changes
Other Study ID Numbers: EW-P-002
Study First Received: August 16, 2011
Last Updated: February 19, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency (PMDA)
Shin-Kasumigaseki Building, 3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013: Japan

Keywords provided by Edwards Lifesciences:
SAPIEN XT Valve (20mm)
Cardiovascular Disease
Valvular Heart Disease
Aortic Stenosis
Heart Valve Therapy
Efficacy endpoints
improvement of Indexed Aortic Valve Area and NYHA functional classification

Additional relevant MeSH terms:
Aortic Valve Stenosis
Constriction, Pathologic
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction
Pathological Conditions, Anatomical processed this record on April 20, 2014