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: February 19, 2014
Last verified: February 2014
  Purpose

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:
    • SAPIEN XT
    • 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

  Eligibility

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

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 %
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01419015

Locations
Japan
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
Investigators
Principal Investigator: Morimasa Takayama, MD Sakakibara Heart Institute
  More Information

No publications provided

Responsible Party: Edwards Lifesciences
ClinicalTrials.gov 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
Transcatheter
Transfemoral
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

ClinicalTrials.gov processed this record on July 20, 2014