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

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: August 24, 2017
Last verified: August 2017
August 16, 2011
August 24, 2017
June 2011
January 2018   (Final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01419015 on ClinicalTrials.gov Archive Site
Adverse Event Rate [ Time Frame: 5 Years ]
Adverse Event Rate
Same as current
Not Provided
Not Provided
 
PREVAIL-20J - Transfemoral Placement of 20mm Aortic Balloon Expandable Transcatheter Valve Trial
A Clinical Trial of a 20mm Transcatheter Bioprosthetic Valve for Patients With Aortic Stenosis
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.

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

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Aortic Valve Stenosis
Device: SAPIEN XT NovaFlex delivery system
Transcatheter aortic valve implantation via transfemoral approach.
Other Names:
  • SAPIEN XT
  • NovaFlex delivery system
Experimental: TAVI-TF Approach
Transcatheter aortic valve implantation and transfemoral approach. SAPIEN XT NovaFlex delivery system will be used.
Intervention: Device: SAPIEN XT NovaFlex delivery system
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
15
December 2018
January 2018   (Final data collection date for primary outcome measure)

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 %
Sexes Eligible for Study: All
19 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT01419015
EW-P-002
Yes
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
Plan to Share IPD: Undecided
Edwards Lifesciences
Edwards Lifesciences
Not Provided
Principal Investigator: Morimasa Takayama, MD Sakakibara Heart Institute
Edwards Lifesciences
August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP