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PREVAIL-20J - Transfemoral Placement of 20mm Aortic Balloon Expandable Transcatheter Valve Trial (PREVAIL-20J)

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ClinicalTrials.gov Identifier: NCT01419015
Recruitment Status : Completed
First Posted : August 17, 2011
Last Update Posted : June 19, 2018
Sponsor:
Information provided by (Responsible Party):
Edwards Lifesciences

Brief Summary:
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 or disease Intervention/treatment Phase
Aortic Valve Stenosis Device: SAPIEN XT NovaFlex delivery system Not Applicable

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


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Clinical Trial of a 20mm Transcatheter Bioprosthetic Valve for Patients With Aortic Stenosis
Actual Study Start Date : June 2011
Actual Primary Completion Date : January 2013
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: TAVI-TF Approach
Transcatheter aortic valve implantation and transfemoral approach. SAPIEN XT NovaFlex delivery system will be used.
Device: SAPIEN XT NovaFlex delivery system
Transcatheter aortic valve implantation via transfemoral approach.
Other Names:
  • SAPIEN XT
  • NovaFlex delivery system




Primary Outcome Measures :
  1. Improvement in indexed Aortic valve area (indexed AVA) and NYHA functional classification. [ Time Frame: 6 Months ]
    Improvement in indexed Aortic valve area (indexed AVA) and NYHA functional classification


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



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 %

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): 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

Responsible Party: Edwards Lifesciences
ClinicalTrials.gov Identifier: NCT01419015     History of Changes
Other Study ID Numbers: EW-P-002
First Posted: August 17, 2011    Key Record Dates
Last Update Posted: June 19, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Edwards Lifesciences:
SAPIEN XT Valve (20mm)
Cardiovascular Disease
Valvular Heart Disease
Aortic Stenosis
Heart Valve Therapy
Transcatheter
Transfemoral
Efficacy endpoints
Indexed Aortic Valve Area
NYHA

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