Status:
COMPLETED
PREVAIL-20J - Transfemoral Placement of 20mm Aortic Balloon Expandable Transcatheter Valve Trial
Lead Sponsor:
Edwards Lifesciences
Conditions:
Aortic Valve Stenosis
Eligibility:
All Genders
19+ years
Phase:
NA
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, an...
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 un...
Eligibility Criteria
Inclusion
- 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
- Aortic valve is congenital unicuspid or bicuspid
- Annulus size between \< 16 mm or \> 19 mm
- LVEF \< 20 %
Key Trial Info
Start Date :
June 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2017
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT01419015
Start Date
June 1 2011
End Date
December 1 2017
Last Update
August 6 2020
Active Locations (4)
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1
Kokura Memorial Hospital
Kitakyushu, Fukuoka, Japan, 802-8555
2
Kurashiki Central Hospital
Kurashiki, Okayama-ken, Japan, 710-8602
3
Osaka University Hospital
Suita, Osaka, Japan, 565-0871
4
Sakakibara Heart Institute
Fuchū, Toyko, Japan, 183-003