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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2014 by Edwards Lifesciences.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01113983
First Posted: April 30, 2010
Last Update Posted: February 21, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Edwards Lifesciences
  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: Intervention Model: Single Group Assignment
Masking: None (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:


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 ]
    improvement in Aortic valve area (AVA) and NYHA functional classification


Secondary Outcome Measures:
  • Adverse Event Rate [ Time Frame: 5 Years ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Edwards Lifesciences
ClinicalTrials.gov Identifier: NCT01113983     History of Changes
Other Study ID Numbers: EW-P-001
First Submitted: April 29, 2010
First Posted: April 30, 2010
Last Update Posted: February 21, 2014
Last Verified: February 2014

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