PREVAIL-20J - Transfemoral Placement of 20mm Aortic Balloon Expandable Transcatheter Valve Trial
This trial is active, not recruiting.
|Condition||aortic valve stenosis|
|Treatment||sapien xt novaflex delivery system|
|Start date||June 2011|
|End date||January 2013|
|Trial size||15 participants|
|Trial identifier||NCT01419015, EW-P-002|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Kitakyushu, Japan||Kokura Memorial Hospital||no longer recruiting|
|Kurashiki, Japan||Kurashiki Central Hospital||no longer recruiting|
|Suita, Japan||Osaka University Hospital||no longer recruiting|
|Fuchu, Japan||Sakakibara Heart Institute||no longer recruiting|
|Intervention model||single group assignment|
Transcatheter aortic valve implantation and transfemoral approach. SAPIEN XT NovaFlex delivery system will be used.
Improvement in indexed Aortic valve area (indexed AVA) and NYHA functional classification.
time frame: 6 Months
Adverse Event Rate
time frame: 5 Years
All participants at least 19 years old.
- Patients who were judged difficult to safely undergo AVR
- Severe senile degenerative aortic valve stenosis
- NYHA Functional Class II or greater
- Signed Informed Consent
- Aortic valve is congenital unicuspid or bicuspid
- Annulus size between < 16 mm or > 19 mm
- LVEF < 20 %
|Official title||A Clinical Trial of a 20mm Transcatheter Bioprosthetic Valve for Patients With Aortic Stenosis|
|Principal investigator||Morimasa Takayama, MD|
|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|
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