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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
  Purpose

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.


Condition Intervention
Aortic Valve Stenosis
Efficacy Endpoints Improvement of Aortic Valve Area and NYHA Functional Classification
 Drug: Transcatheter aortic valve implantation

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 Transcatheter Bioprosthetic Valve for Patients With Aortic Stenosis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Edwards Lifesciences:

Primary Outcome Measures:
  • 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


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


Estimated Enrollment: 69
Study Start Date: April 2010
Estimated Study Completion Date: April 2016
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Transcatheter aortic valve implantation
    Transcatheter aortic valve implantation via transfemoral or transapical approach
    Other Names:
    • SAPIEN XT
    • NovaFlex delivery system
    • Ascendra2 delivery system
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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 %

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01113983

Locations
Japan
Kurashiki Central Hospital
Kurashiki, Okayama, Japan, 710-8602
Osaka University Hospital
Suita, Osaka, Japan, 565-0871
Sakakibara Heart Institute
Chofu, Tokyo, Japan, 183-0003
Sponsors and Collaborators
Edwards Lifesciences
  More Information

No publications provided

Responsible Party: Edwards Lifesciences
ClinicalTrials.gov Identifier: NCT01113983     History of Changes
Other Study ID Numbers: EW-P-001
Study First Received: April 29, 2010
Last Updated: March 6, 2013
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, Cardiovascular Disease, Valvular Heart Disease, Aortic Stenosis, Heart Valve Therapy, Transapical, Transcatheter, Transfemoral

Additional relevant MeSH terms:
Aortic Valve Stenosis
Constriction, Pathologic
Heart Valve Diseases
Heart Diseases
 Cardiovascular Diseases
Ventricular Outflow Obstruction
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on May 21, 2013