Transfemoral Placement of 20mm Aortic Balloon Expandable Transcatheter Valve Trial (JAPAN)
This trial is active, not recruiting.
|Condition||aortic valve stenosis|
|Treatment||transcatheter aortic valve implantation (sapien xt novaflex delivery system)|
|Start date||June 2011|
|End date||April 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|
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
Improvement in indexed Aortic valve area (indexed AVA) and NYHA functional classification.
time frame: 6 Months
Adverse Event Rate
time frame: 5 Years
Male or female participants of any age.
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 %
|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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